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| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00000172 | completed | 1 | phase 3 | ['alzheimer disease'] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['galantamine'] | ['[H][C@]12C[C@@H](O)C=C[C@]11CCN(C)CC3=C1C(O2)=C(OC)C=C3'] | Inclusion Criteria: - Probable Alzheimer's disease - Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18 - Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18 - Opportunity for Activities of Daily Living - Caregiver - Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject. Exclusion Criteria: - Conditions that could confound diagnosis - Neurodegenerative disorders - Acute cerebral trauma - Psychiatric disease - More than one infarct on CT/MRI scans - History of alcohol or drug abuse - Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block. | |
| 2 | NCT00000173 | completed | 1 | phase 3 | ['alzheimer disease'] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['donepezil', 'vitamin e'] | ['O=S(=O)(C1=CC=CC=C1)C1=CN=C2C(C=CC=C2N2CCNCC2)=C1', 'CC(C)CCC[C@@H](C)CCC[C@@H](C)CCC[C@]1(C)CCC2=C(O1)C(C)=C(C)C(O)=C2C'] | Inclusion Criteria: - Memory complaints and memory difficulties which are verified by an informant. - Abnormal memory function documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25): a) less than or equal to 8 for 16 or more years of education, b) less than or equal to 4 for 8-15 years of education, c) less than or equal to 2 for 0-7 years of education. - Mini-Mental Exam score between 24 and 30 (inclusive) (Exceptions may be made for subjects with less than 8 years of education at the discretion of the project director.). - Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5. - General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit. - No significant cerebrovascular disease: Modified Hachinski score of less than or equal to 4. - Age between 55 and 90 (inclusive). - Permitted medications stable for at least 1 month prior to screening. In particular: a) Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 2 years). b) Estrogen replacement therapy is permissible. c) Ginkgo biloba is permissible, but discouraged. - Hamilton Depression rating scale score of less than or equal to 12 on the 17-item scale. - Informant is available who has frequent contact with the subject (e.g. an average of 10 hours per week or more), agrees to monitor administration of study drug, observe for adverse events, and accompany the subject to all clinic visits for the duration of the protocol. - CT or MRI scans within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. A lacune in a non-critical brain area which is not believed to contribute to the subject's cognitive impairment is permissible. - Adequate visual and auditory acuity to allow neuropsychological testing. - Good general health with no additional diseases expected to interfere with the study. - Normal B12, RPR, and Thyroid Function Tests or without any clinically significant abnormalities that would be expected to interfere with the study. - ECG without clinically significant abnormalities that would be expected to interfere with the study. - Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). - Agreement not to take other vitamin supplements (including Vitamin E), multivitamins, other than those provided by the study. Exclusion Criteria: - Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. - Major depression or another major psychiatric disorder as described in DSM IV within the past 2 years. - Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol. - History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria). - History of schizophrenia (DSM IV criteria). - Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including: a) History of systemic cancer within the last 5 years (non-metastatic skin cancers are acceptable). b) History of myocardial infarction within the past year or unstable or severe cardiovascular disease including angina or CHF with symptoms at rest. c) Clinically significant obstructive pulmonary disease or asthma. d) Clinically significant and unstable gastrointestinal disorder such as ulcer disease or a history of active or occult gastrointestinal bleeding within two years. e) Clinically significant laboratory test abnormalities on the battery of screening tests (hematology, prothrombin time, chemistry, urinalysis, ECG). f) Insulin-requiring diabetes or uncontrolled diabetes mellitus. g) Uncontrolled hypertension (systolic BP greater than 170 or diastolic greater than 100). h) History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years. - Medications a) Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening. b) Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening. c) Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening. d) Use of long-acting benzodiazepines or barbituates within 4 weeks prior to screening. e) Use of short-acting anxiolytics or sedative hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of screening). f) Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable). g) Use of systemic corticosteroids within 3 months prior to screening. h) Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening. i) Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening. j) Use of warfarin (Coumadin) within 4 weeks prior to screening. - Vitamin Supplements a) Use of vitamin supplements other than standard multivitamin included as part of the treatment intervention used in this protocol within 2 weeks prior to screening. - Any prior use of any FDA approved medications for the treatment of Alzheimer's disease (e.g. tacrine, donepezil, or other newly approved medications). - Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening. - Subjects who, in the investigator's opinion, will not comply with study procedures. | |
| 3 | NCT00000174 | completed | 0 | phase 3 | ['alzheimer disease', 'cognition disorders'] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']", "['F20.81', 'F21', 'F34.0', 'F34.1', 'F42.3', 'F45.0', 'F51.5']"] | ['rivastigmine'] | ['CCN(C)C(=O)OC1=CC=CC(=C1)[C@H](C)N(C)C'] | Inclusion Criteria: - Are aged 55-85 years, inclusive. Subjects older than 85 years may be eligible to participate, with approval of the designated study medical monitor. - Are male or female without child-bearing potential (i.e., surgically sterilized [via bilateral tubal ligation,bilateral oophorectomy, or hysterectomy], at least one year postmenopausal, or using adequate birth control). - Are cooperative, able to ingest oral medication, and willing to complete all aspects of the study. - Will provide written informed consent prior to their participation in the study. - Show evidence of mild cognitive impairment (MCI) by meeting all of the following criteria: Global CDR score = 0.5, NYU Delayed Paragraph Recall less than 9, 17-item HAM-D score less than 13, and HAM-D Item 1 (depressed mood) score =1. - Have a friend or family member who is willing to participate in the study as an informant. The informant must see the subject at least once a week for several hours and be available to accompany the subject to the screening and baseline visits, and at a minimum, be accessible by telephone for other scheduled visits. Exclusion Criteria: - Advanced, severe, and unstable disease of any type that may interfere with primary and secondary variable evaluations including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the subject to a significant degree or put the subject at special risk. - Cognitive impairment sufficient to warrant a diagnosis of dementia. - Met the DSM-IV and NINCDS-ADRDA criteria for AD. - A clinical diagnosis of AD. - A DSM-IV Axis 1 diagnosis. However, subjects with current depression are eligible after appropriate treatment of the depressive episode. A minimum of four weeks washout of antidepressant medication should occur prior to screening. Subjects with a prior history of depression (but not currently depressed) are allowed in the study. - Fewer than four years of formal education. - A documented history of transient ischemic attacks. - Baseline MRI findings or CT-scan findings within a year of screening that are consistent with a process other than AD, e.g., stroke, tumor, brain trauma or hydrocephalus, that may contribute to the subject's MCI. Lacunae infarcts present in areas affecting cognition (entorhinal cortex, hippocampus, medial temporal lobe) will also exclude the subject from the study. - A score of greater than 4 on the Modified Hachinski Ischemic Scale. - A current diagnosis of any primary neurodegenerative disorder, e.g., Parkinson's disease. - A current diagnosis of uncontrolled seizure disorder. - A current diagnosis of active peptic ulceration. - A current diagnosis of severe and unstable cardiovascular disease. - A current diagnosis of sick-sinus syndrome or conduction deficits (sino-atrial block, second or third degree atrio-ventricular block). - A current diagnosis of acute, severe, or unstable asthmatic conditions. - A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to Exelon or to other cholinergic compounds (e.g., pilocarpine, bethanechol, tacrine, velnacrine, donepezil, metrifonate, or physostigmine). Subjects who have experienced elevations in liver function test parameters on other cholinesterase inhibitors are still eligible. - Taken any of the following substances: An investigational drug during the past four weeks; Metrifonate during the past three months; a drug or treatment known to cause major organ system toxicity during the past four weeks; other cholinergic drugs (e.g., donepezil, tacrine, succinylcholine-type muscle relaxants) during the past two weeks (topical pilocarpine will be permitted); antidepressant medication during the past four weeks. - Participated in a previous clinical trial of Exelon. - Clinically important laboratory abnormalities in serum B12, folate, or T3/T4 at screening. The subject should be excluded if peripheral neuropathy, macrocytic anemia, or myxedema is present. - If screen values do not meet the absolutely exclusionary values given below but are still outside the normal reference range, treatment for folic acid/B12 deficiency or thyroid disorder, as appropriate, may be initiated or adjusted with re-evaluation of the subject within three months. Within these three months of treatment, the subject's cognitive condition must be clinically unchanged or worse for the subject to be acceptable. Once accepted, the subject must remain on the appropriate treatment throughout the study. - Exclude if T3 uptake is less than 19%; T4 less than 2.9 ((g/dL); free T4 index is less than 0.8 - Exclude if folate less than 1.7 ng/ml (normal range greater than 1.9) - Exclude if B12 less than 100 pg/ml (normal range greater than 200) - A positive rapid plasmin reagin test followed up by a positive serological test for syphilis. - A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, severe language difficulty). | |
| 4 | NCT00000390 | completed | 1 | phase 2 | ['depression'] | ["['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['imipramine hydrochloride'] | ['CN(C)CCCN1C2=CC=CC=C2CCC2=CC=CC=C12'] | Inclusion Criteria: - Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented. - May have been alcoholic or drug abuser 6 months previous. - Unspecified - CD4 Unspecified. Exclusion Criteria: - Non ambulatory patients or those requiring extensive help in self care are excluded. - Non ambulatory patients or those requiring extensive help in self care are excluded. - Current alcohol or drug abuse. - Unspecified | |
| 5 | NCT00000419 | terminated | 0 | phase 3 | ['systemic lupus erythematosus'] | ["['M32.9', 'M32.0', 'M32.11', 'M32.12', 'M32.13', 'M32.14', 'M32.8']"] | ['premarin and provera'] | ['[H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)CC[C@]12C'] | Inclusion Criteria: - Female - Unequivocal diagnosis of SLE - Inactive disease or stable on 0.5 mg/kg/day or less of prednisone - Chemical evidence of menopause or have stopped periods for at least 6 months Exclusion Criteria: - Blood pressure >145/95 on three occasions - Deep vein, arterial thrombosis or pulmonary embolus - GPL >40; MPL >40; APL >50; dRVVT >37 sec - APL antibody syndrome ever - Gynecologic or breast cancer - Hepatic dysfunction or liver tumors - Diabetes mellitus (NOT due to steroids) with vascular disease - Congenital hyperlipidemia - Complicated migraine - Severe disease activity (SLEDAI >12) - Increase in SLEDAI >2 points in 3 months - Unexplained vaginal bleeding - Use of estrogen (HRT or OCP) for >1 month at any time after SLE diagnosis - FSH <40 - Premenopausal myocardial infarction | |
| 6 | NCT00000577 | withdrawn | record is an acrn grant summary & not reflective of an individual trial. all acts conducted by acrn were individually registered on the prs. | 0 | phase 3 | ['asthma', 'lung diseases'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']", "['J84.115', 'M05.10', 'M05.111', 'M05.112', 'M05.119', 'M05.121', 'M05.122']"] | ['albuterol', 'colchicine', 'adrenal cortex hormones', 'adrenergic-beta agonists'] | ['CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1', 'COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O'] | Patients with asthma; specific eligibility criteria vary for each study. |
| 7 | NCT00000614 | completed | 1 | phase 3 | ['cardiovascular diseases', 'heart diseases', 'peripheral vascular diseases', 'thromboembolism', 'vascular diseases', 'venous thromboembolism'] | ["['A52.00', 'A52.09', 'A50.54', 'Z01.810', 'Q87.418', 'Z13.6', 'R94.30']", "['I11.0', 'I11.9', 'I27.1', 'I51.9', 'I09.9', 'I27.9', 'I01.8']", "['I73.9', 'I73.89']", "['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']", "['I73.9', 'D57.03', 'D57.213', 'G46.8', 'I73.89']", "['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['warfarin'] | ['S1SSSSSSS1'] | Patients with venous thromboembolism, including patients with factor V Leiden. Patients had completed prescribed anticoagulation therapy within the last two years before the trial and were not currently on anticoagulation therapy. | |
| 8 | NCT00000811 | completed | 0 | phase 2 | ['bacterial infections', 'pneumonia, pneumocystis carinii', 'hiv infections'] | ["['A49.9', 'A04.9', 'A04.8', 'A49.8']", "['Z21']"] | ['azithromycin', 'atovaquone', 'sulfamethoxazole-trimethoprim'] | ['[H][C@]12SC(C)(C)[C@@H](N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=CC=C1)C(O)=O', 'OC1=C([C@H]2CC[C@@H](CC2)C2=CC=C(Cl)C=C2)C(=O)C2=CC=CC=C2C1=O'] | Inclusion Criteria Children may be eligible for this study if they: - Are HIV-positive. - Are between the age of 3 months and 18 months (consent of parent or guardian required). (This study has been changed. In an earlier version, patients up to 19 years old were eligible.) - Are at risk for developing pneumonia and need preventive treatment. - Have a CD4 count of less than 1,500 cells/mm3 if under 1 year of age or a CD4 count of less then 500 cells/mm3 if between 1 and 2 years of age. Exclusion Criteria Children will not be eligible for this study if they: - Have an infection that requires treatment. - Are allergic to atovaquone, azithromycin, or SMX/TMP. - Have serious diarrhea for more than 1 week. | |
| 9 | NCT00000897 | completed | 0 | n/a | ['hiv infections'] | ["['Z21']"] | ['zidovudine'] | ['CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O'] | Inclusion Criteria Men and women may be eligible for this study if they: - Are HIV positive. Women may be eligible for this study if they: - Have regular periods and a normal gynecological exam, (including a Pap smear and mammogram). - Enter the study between Days 10 and 18 of the first day of their last period. - Are willing to use either the Pill or Depo-Provera as birth control. - Have a negative pregnancy test within 14 days prior to study. Exclusion Criteria Men and women will not be eligible for this study if they: - Cannot take ZDV for any reason. - Have cancer. - Are taking stavudine. Women will not be eligible for this study if they: - Cannot take the Pill or Depo-Provera. - Are pregnant or nursing. - Are receiving nelfinavir and want to enroll in Step 2. - Have a history of chronic high blood pressure, thrombophlebitis, and/or pulmonary emboli if participating in Step 2 of the study. (This study has been changed so that women with certain criteria are excluded from participating in Step 2.) | |
| 10 | NCT00000914 | completed | 0 | n/a | ['hiv infections'] | ["['Z21']"] | ['indinavir sulfate', 'ritonavir', 'nelfinavir mesylate', 'efavirenz'] | ['CC(C)(C)NC(=O)[C@@H]1CN(CC2=CN=CC=C2)CCN1C[C@@H](O)C[C@@H](CC1=CC=CC=C1)C(=O)N[C@@H]1[C@H](O)CC2=CC=CC=C12', 'CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)COC1=C(C)C=CC=C1C)CC1=CC=CC=C1', '[H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSC1=CC=CC=C1)NC(=O)C1=C(C)C(O)=CC=C1)[C@@H](C2)C(=O)NC(C)(C)C', '[H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C'] | Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have an HIV RNA count of at least 400 copies/ml. - Are at least 13 years old (need consent if under 18). - Have been on antiretroviral treatment (including at least 2 NRTIs) for at least 16 weeks prior to study entry. - Agree to practice abstinence or to use effective methods of birth control, including a barrier method, during the study. Exclusion Criteria You will not be eligible for this study if you: - Are pregnant or breast-feeding. - Have active opportunistic (HIV-associated) infections. - Have taken nelfinavir (NFV) for more than 2 weeks after failing indinavir/ritonavir (IDV/RTV) treatment or have taken IDV/RTV for more than 2 weeks after failing NFV treatment. - Have used any protease inhibitor other than NFV or IDV/RTV for more than 2 weeks. - Have used any non-nucleoside reverse transcriptase inhibitor (NNRTI) for more than 1 week. | |
| 11 | NCT00001132 | completed | 0 | phase 2 | ['hiv infections'] | ["['Z21']"] | ['abacavir sulfate'] | ['NC1=NC2=C(N=CN2[C@@H]2C[C@H](CO)C=C2)C(NC2CC2)=N1'] | Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have been taking anti-HIV therapy that includes at least 3 anti-HIV drugs and is an acceptable anti-HIV drug combination for 60 to 104 days before study treatment. Patients must not have changed any of the drugs in the 28 days before study entry. (This study has been changed by extending the number of days that anti-HIV therapy has been received.) - Have a viral load greater than 500 but less than or equal to 10,000 copies/ml and have had a significant decrease in viral load between 49 and 84 days after starting this anti-HIV therapy. (This study has been changed by extending the length of time of viral load decrease.) - Are at least 13 years old (consent of parent or guardian required if under 18). - Agree to practice abstinence or use barrier method of birth control (such as condoms) during the study and for 3 months after. Exclusion Criteria Patients will not be eligible for this study if they: - Have ever taken ABC. - Have received anti-HIV therapy for more than 104 days in the past. (This study has been changed by extending the number of days that anti-HIV therapy has been received.) - Have a fever for 7 days in the 30 days before study entry. - Have cancer, including Kaposi's sarcoma, that requires chemotherapy. - Have an active infection that requires treatment in the 21 days before study entry. - Have any opportunistic (AIDS-related) infection or disease that requires a change in medication in the 14 days before study entry. - Have any medical condition or history of an illness that the doctor feels would place them at risk or make them unable to complete the study. - Are taking drugs that affect the immune system or any experimental anti-HIV drugs, except for their current drug combination. - Are taking St. John's wort. (This study has been changed. Previously, patients taking St. John's wort were eligible.) - Have received a vaccine in the 21 days before study entry. - Are pregnant or breast-feeding. | |
| 12 | NCT00001596 | completed | 0 | phase 2 | ['albinism', 'inborn errors of metabolism', 'oculocutaneous albinism', 'platelet storage pool deficiency', 'pulmonary fibrosis'] | ["['J84.10', 'J84.112', 'E84.0', 'J84.178']"] | ['pirfenidone', 'placebo'] | ['CC1=CN(C(=O)C=C1)C1=CC=CC=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | - INCLUSION CRITERIA For the portion of the protocol involving continuations of pirfenidone treatment, the criteria are simply previous enrollment in 97-HG-0085. For enrollment in the new clinical trial, the inclusion criteria involve enrollment in protocol 95-HG-0193, "Clinical and Basic Investigations into Hermansky-Pudlak Syndrome". This itself requires a diagnosis of HPS based upon molecular grounds or the electron microscopic demonstration of deficiency of platelet dense bodies. In addition, for protocol 97-HG-0085, patients must: - Be over 18 years of age. - Have an FVC greater than 50 percent and less than or equal to 85 percent of predicted OR a hemoglobin-corrected DL(co) greater than 35 percent and less than or equal to 80 percent of predicted, with no evidence of a pulmonary embolism. - Have evidence of reduced exercise tolerance lasting longer than one week on either the St. George's Hospital Respiratory Questionnaire or the Dyspnea Perception Scale. - FEV(1)/FVC greater than 80 percent of predicted after bronchodilators. - No evidence of improvement in pulmonary fibrosis within the past year defined as an FVC increased by 10 percent or a DL(co) increased by 15 percent. - Distance walked greater than or equal to 150 meters (492 feet) with oxygen saturation greater than or equal to 83 percent on less than or equal to 6 L/min. of oxygen during the 6-Minute Walk Test (6MWT). - Be available, willing, and able to come to the NIH Clinical Center for admission every 4 months for three years. EXCLUSION CRITERIA - History of clinically significant environmental exposure known to cause pulmonary fibrosis (including but not limited to drugs, asbestos, beryllium, radiation, domestic birds). - An explanation for interstitial lung disease other than HPS, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, cancer. - Diagnosis of any connective tissue disease including but not limited to scleroderma, systemic lupus erythematosus, rheumatoid arthritis. - Listing on a lung transplantation waiting list. - Pregnancy or lactation - Cigarette smoking in the past 6 months - History of ethanol abuse or recreational drug use in the past two years - History of human immunodeficiency virus (HIV) or chronic viral hepatitis infection - Chronic use of high-dose steroids (greater than 10 mg prednisone/day) - Prior use of pirfenidone - Use of any of the following within 28 days of enrollment: investigational therapy, cytotoxic/immunosuppressive agents other than corticosteroids (including but not limited to azathioprine, cyclosphosphamide, methotrexate, cyclosporine); cytokine modulators (including but not limited to etanercept and infliximab); therapies targeted to treat pulmonary fibrosis (including but not limited to D-penicillamine, colchicine, interferon gamma-1b, bosentan, N-acetylcysteine - Any severe medical complication including but not be limited to uncontrolled seizures, repeated transient ischemic attacks, abnormal mental status, severe ataxia, uncontrolled migraine headaches, diplopia, repeated episodes of syncope, untreated clinical depression, recent myocardial infarction (past 6 months), unstable angina, clinically relevant arrhythmias, uncontrolled hypotension or hypertension (systolic blood pressure less than 80 or greater than 180 mm Hg), myocarditis, hepatomegaly (liver greater than 3 cm below the right costal margin), renal glomerular impairment (creatinine clearance less than 35 ml/min/1.73 m2, pancreatitis, toxic thyroiditis, malignancy (except basal cell carcinoma) - Medications with a high frequency of life threatening side effects - Significant laboratory abnormalities, including but not limited to serum potassium less than 3.0 or greater than 5.4 mEq/L, SGPT greater than 100 U/L, CK greater than 700 U/L, hemoglobin less than 9.0 g/dL, platelets less than 70 k/mm3, leucocyte count less than 2.0 k/microliter, or cholesterol greater than 400 mg/dL. - For women of child bearing age, failure to have an effective method of birth control. | |
| 13 | NCT00001723 | completed | 1 | phase 2 | ['diabetes mellitus', 'hypertension', 'metabolic disease', 'obesity', 'sleep apnea syndrome'] | ["['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']", "['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']", "['Z86.39', 'O99.280', 'O99.281', 'O99.282', 'O99.283', 'O99.284', 'O99.285']", "['E66.8', 'E66.9', 'E66.1', 'O99.214', 'O99.215', 'O99.210', 'O99.211']", "['G47.30', 'G47.39', 'G47.31', 'G47.33', 'P28.3', 'G47.37']"] | ['orlistat', 'placebo'] | ['CCCCCCCCCCC[C@@H](C[C@@H]1OC(=O)[C@H]1CCCCCC)OC(=O)[C@H](CC(C)C)NC=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | - INCLUSION CRITERIA: Good general health. Individuals taking medications for obesity-related comorbid conditions will not be excluded. Obesity: body mass index for age and triceps skinfold above the 95th percentile (determined by NHANES I age-, sex-, and race- specific data). All subjects will be required to be over 60 kg in body weight. Evidence for a quantifiable obesity-related comorbidity. Examples include: systolic or diastolic hypertension (determined by age-specific charts); frank Type 2 diabetes, impaired glucose tolerance assessed by oral glucose tolerance testing; hyperinsulinemia (defined as a fasting insulin greater than 15 mIU/mL); significant hyperlipidemia (total cholesterol greater than 200 mg/dL, LDL cholesterol greater than 129 mg/dL or fasting triglycerides greater than 200 mg/dL); hepatic steatosis (SGPT or SGOT above normal range with negative hepatitis studies) or sleep apnea documented by a sleep study. Age 12 to 17 years at the start of the study. For girls with childbearing potential, a negative pregnancy test before taking and while taking study medication. Sexually active females must be using an effective form of birth control. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended. Race of all four grandparents self-identified as either all Caucasian or all African American. EXCLUSION CRITERIA: Volunteers will be excluded (and referred to non-experimental treatment programs) for the following reasons: Presence of renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome), or pulmonary disorders (other than either asthma not requiring continuous medication or sleep apnea-related disorders); Adolescent girls who are pregnant, who are currently nursing an infant, or who are having unprotected intercourse; Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study; Subjects who regularly use prescription medications unrelated to the complications of obesity. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication for at least 3 months prior to study entry may be eligible; Recent use (within six months) of anorexiant medications for the purpose of weight reduction; Inability to undergo MRI (e.g., volunteers with metal within their bodies including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices such as infusion pumps, nerve stimulators, bone growth stimulators, etc. that are contraindications). For pilot study participants, hypersensitivity or allergy to methylene blue. Individuals with documented G6PD deficiency will be excluded. INCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS: Volunteers will qualify for inclusion if they meet the following criteria: 1. Good general health. 2. Age 12-17 years at study entry. 3. Body mass index (BMI) for age above the 5th percentile and below 85th percentile, which is considered normal weight by CDC growth chart standards. 4. For females with childbearing potential, a negative pregnancy test at initial evaluation. 5. Race of all four grandparents self-identified as either all Caucasian or all African American. EXCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS: Volunteers will be excluded for the following reasons: 1. Presence of past or present medical problems which would impair performance during the exercise tests; 2. Females who are pregnant, or who are currently nursing an infant; 3. Individuals who have, or whose parent or guardian has, current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or possibly hinder completion of the study; 4. Recent weight change of more than 3% of body weight in the past two months; 5. Recent use (within six months) of anorexiant medications for the purpose of weight reduction; 6. Physical impairments that would prevent completion of either the walk/run test or the cycle test. | |
| 14 | NCT00002523 | completed | 1 | phase 3 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['fluorouracil', 'leucovorin calcium'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1'] | DISEASE CHARACTERISTICS: - Histologically confirmed resectable adenocarcinoma of the rectum - Any grade - Tumor macroscopically within 15 cm of anal margin on rigid rectoscopy - Tumor tethered or partially fixed on digital rectal exam and/or T3-4 on rectal ultrasound - No acute or subacute bowel obstruction without colostomy diversion - No chronic inflammatory disease of the ileum and/or colon - No primary adenocarcinoma of the anal canal - No distant metastasis PATIENT CHARACTERISTICS: Age: - 80 and under Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count greater than 2,000/mm^3 - Platelet count greater than 130,000/mm^3 Hepatic: - Not specified Renal: - Creatinine less than 1.36 mg/dL Cardiovascular: - No angina pectoris Other: - No other prior malignancy except basal cell skin cancer or carcinoma in situ of the uterine cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy for adenocarcinoma of the rectum Chemotherapy - No prior chemotherapy for adenocarcinoma of the rectum Endocrine therapy - No prior endocrine therapy for adenocarcinoma of the rectum Radiotherapy - No prior radiotherapy for adenocarcinoma of the rectum Surgery - No prior surgery for adenocarcinoma of the rectum | |
| 15 | NCT00002525 | terminated | the study was stopped before reaching its accrual goal due to slow accrual | 0 | phase 3 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['fluorouracil', 'leucovorin calcium'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1'] | Eligibility Criteria for Randomization: Inclusion Criteria: - Adenocarcinoma of the colon documented by colonoscopy or barium enema - Tumor either considered resectable or totally resected within 24 hours prior to study - Randomization within 2 weeks prior to surgery or within 24 hours after surgery required - Patients randomized after surgery must meet the following criteria: - Complete resection performed with no evidence of residual disease or distant metastases - Distal margin of tumor above the peritoneal reflection in area of rectum - No free perforation Intestinal obstruction allowed - Preliminary or complementary colostomy allowed - Concurrent registration for E3293 strongly recommended - Age 18 and over - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Adequate organ function based on the following tests within 2 weeks prior to randomization - White Blood Cell (WBC) at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 2.0 mg/dL - Creatinine no greater than 2.0 mg/dL - No second malignancy within 5 years except: superficial non-melanomatous skin cancer and carcinoma in situ of the cervix - Fertile patients must use adequate contraception Exclusion Criteria: - Dual primary tumors - Prior nonmalignant systemic disease that would preclude use of chemotherapy - Pregnant or nursing - Prior fluorouracil - Other prior or concurrent chemotherapy for this malignancy - Prior or concurrent radiotherapy for this malignancy Eligibility Criteria for Re-registration for Patients Randomized Pre-operatively: - Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution. - Must be re-registered < 35 days after surgery. - ECOG performance status of 0-2. - Complete resection must have been performed with no evidence of residual disease or distant metastasis. - Distal margin of the tumor must not extend below the peritoneal reflection in the area of the rectum. - Single primary colon carcinoma without free perforation demonstrated. Patients with intestinal obstruction are eligible. Preliminary or complementary colostomy dose not preclude entry of a patient. - Have WBC > 3000/mm^3, platelets > 100,000/mm^3, adequate renal (serum creatinine <= 2.0mg/dL) and hepatic function (bilirubin <= 2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only). Eligibility Criteria for Re-registration for Patients Randomized Post-operatively: - Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution. - Patient must be re-registered < 35 days after surgery. - ECOG performance status of 0-2. - Started perioperative 5-FU, if assigned, within 24 hours of surgery. - Have WBC > 3000/mm^3, platelets > 100,000/mm^3, adequate renal (serum creatinine <= 2.0mg/dL) and hepatic function (bilirubin < =2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only). |
| 16 | NCT00002549 | unknown status | 1 | phase 3 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['busulfan', 'cyclophosphamide', 'cytarabine', 'daunorubicin hydrochloride', 'etoposide', 'idarubicin', 'mesna', 'mitoxantrone hydrochloride'] | ['CS(=O)(=O)OCCCCOS(C)(=O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(C)=O)C(O)=C1C2=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', '[H][C@@]12C[C@H](N(C(=O)[C@H](C)N[C@@H](CCC3=CC=CC=C3)C(=O)OCC)[C@@]1([H])CCCC2)C(O)=O', 'OS(=O)(=O)CCS', 'OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O'] | DISEASE CHARACTERISTICS: Newly diagnosed acute myeloid leukemia (AML) of any FAB histology (M1-M7) except M3 At least 30% blast cells in bone marrow smears Secondary leukemias eligible, as follows: Following cured malignancies, including Hodgkin's disease Following exposure to alkylating agents or radiotherapy for other reasons The following leukemias are excluded: Blast crisis of chronic myeloid leukemia Leukemia secondary to other myeloproliferative disease Leukemia secondary to myelodysplastic syndrome of more than 6 months' duration No other progressive malignant disease PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: Not specified Hematopoietic: Not applicable Hepatic: Bilirubin no greater than 1.5 x ULN Renal: Creatinine no greater than 1.5 x ULN Cardiovascular: No severe heart failure requiring diuretics or with an LVEF less than 50% Other: No severe concomitant neurologic disease No severe concomitant psychologic disease PRIOR CONCURRENT THERAPY: No prior therapy for AML (chemotherapy, radiotherapy, or more than 7 days of corticosteroids) | |
| 17 | NCT00002556 | completed | 0 | phase 3 | ['stage i multiple myeloma', 'stage ii multiple myeloma', 'stage iii multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']", "['C90.01', 'C90.02', 'C90.00']", "['C90.01', 'C90.02', 'C90.00']"] | ['vincristine sulfate', 'carmustine', 'melphalan', 'cyclophosphamide', 'prednisone'] | ['CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1', 'ClCCNC(=O)N(CCCl)N=O', 'N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C'] | Inclusion Criteria: - Patients must have a diagnosis of multiple myeloma confirmed by the presence of: - Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytoma - In addition, at least 1 of the following ancillary criteria must be documented: - M-protein in the serum - M-protein in the urine - Radiographic evidence of osteolytic lesions (generalized osteoporosis qualifies only if the bone marrow aspirate contains >= 20% plasma cells) - Patients must have measurable disease; the following will constitute measurable disease; tests used to document measurable disease must be done within two weeks prior to registration; a bone marrow biopsy performed =< 6 weeks prior to registration is acceptable; Note: If present, all of these parameters must be followed for response - Serum M-protein >= 1.0 g/dL by serum protein electrophoresis - Urine M-protein (light chain) excretion > 200 mg/24 hours by urine protein electrophoresis - Measurable plasmacytoma(s) of soft tissue (must be biopsy proven) - Bone marrow plasmacytosis >= 20% - Patients must not have been previously treated with chemotherapy; prior treatment of hypercalcemia with corticosteroids, bisphosphonates, or other agents does not disqualify the patient - Patients refuses entry or is ineligible for S9321; Note: S9321, "Standard Dose Versus Myeloablative Therapy for Previously Untreated Symptomatic Multiple Myeloma" has priority over E5A93; patients with previously untreated multiple myeloma should be entered on S9321; patients who are ineligible for or decline entry to S9321 should be entered on E5A93 and E3A93 if eligible - Patients treated with local radiotherapy to > 15% of the bone marrow area are ineligible; patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed; if, in the physician's opinion, the delay in systemic therapy would itself pose undue risk, the patient may be entered and receive concurrent radiotherapy; in this situation, for the first VBMCP cycle, Melphalan, BCNU and Cyclophosphamide should be given at 75% of the dose - Patients with Stages I, II, or III disease according to a modification of the clinical staging system by Durie and Salmon are eligible; staging should be based on values obtained at the time of diagnosis unless patient has had a more abnormal value prior to supportive treatment, transfusion, etc.; include only values obtained prior to initiation of protocol treatment - Pretreatment x-rays must be done within 6 weeks of registration; copies of the bone x-ray reports are required and must be submitted with on-study forms - Bone marrow slides must be submitted - Absolute neutrophil count (ANC) >= 1,000/mm^3 - Platelet count >= 50,000/mm^3 - Creatinine =< 5.0 mg/dL (NOTE: Patients with creatinine 2.0-5.0 mg/dL may be admitted to this study but must receive altered doses and schedules of therapy) - Patients requiring dialysis are not eligible - Bilirubin =< 2.0 mg/dL - Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x upper limit of normal - Alkaline phosphatase =< 2.5 x upper limit of normal - No myocardial infarction within previous 6 months, no significant arrhythmia within the prior 3 months; if hypertension is present, it should be under control prior to study entry - Patients with a history of congestive heart failure or myocardial infarction must have a normal myocardial ejection fraction as determined by echogram or multiple gate acquisition (MUGA) scan - No patient with angina requiring nitrates or beta blockers, or with a history of thrombophlebitis or pulmonary emboli within the previous 6 months and currently requiring anticoagulants - Patients with concurrent reversible conditions, e.g., infection, hyperuricemia, cord compression, hyperviscosity syndrome, central nervous system (CNS) complications, or renal disease may be entered into this study after appropriate therapy for these complications is initiated and the condition is controlled; therapy must be fully documented and dated on the on-study form; Note: Hypercalcemia patients may be entered directly on study and may receive corticosteroids, bisphosphonates, or other agents as needed for control of hypercalcemia; Note: Anemia patients may be entered directly on study and may receive erythropoietin (epoetin alfa: Procrit, Epogen, Aranesp, etc.) or other agents as needed for control of anemia - No smoldering multiple myeloma, nonsecretory myeloma, localized plasmacytomas, monoclonal gammopathy of undetermined significance (MGUS), or primary systemic amyloidosis (AL) - No patient with second malignancies except: those treated with surgery alone who are disease free > 5 years or patients whose only other malignancy is non-melanoma skin cancer or carcinoma in situ of the cervix - Patients >= 70 years must have a performance status of 0-2, and be specifically evaluated by their physician to determine if they can tolerate either regimen; they should not enter the study if the physician feels that they would be unable to tolerate either regimen - Female patients of childbearing potential must have a negative pregnancy test documented before entering this study; these patients must be provided adequate guidance about birth control measures; lactating women will be ineligible - Pre-treatment baseline Eastern Cooperative Oncology Group (ECOG) Performance Status must be assessed - Patients that are known to have acquired immune deficiency syndrome (AIDS) are excluded from this trial because the safety of the agents on this population has not been established - Participation in E3A93 is mandatory for all patients in E5A93; patients must be registered separately to each protocol, first to E5A93, then to E3A93; NOTE: Study participants from South African institutions are exempt from mandatory registration to E3A93 due to costs and problems associated with international shipping - Patients must give written informed consent | |
| 18 | NCT00002570 | completed | 0 | phase 3 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['fluorouracil', 'leucovorin calcium'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1'] | DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cancer of the colon or rectum that is locally advanced or metastatic Primary lesion was or is located in the large bowel as confirmed by endoscopy, radiology, or surgery Radiologic or clinical evidence of metastasis subsequent to resection does not require histologic or cytologic confirmation unless: Interval between primary surgery and development of metastasis is greater than 5 years OR Primary cancer was Dukes' A or B1 Ineligible for potentially curative therapy, e.g.: Surgical resection of a limited hepatic or pulmonary metastasis Irradiation of locally recurrent colon or rectal cancer No or minimal symptoms related to the cancer, i.e.: No persistent pain requiring regular narcotic analgesia No persistent fever greater than 38 degrees C No symptomatic bowel obstruction No persistent nausea requiring medication No weight loss of greater than 5 kg over the previous 3 months unless clearly not associated with the cancer (e.g., associated with surgery or intercurrent illness) Symptomatic relapse/metastases rendered asymptomatic by secondary surgery or radiotherapy are eligible provided the patient remains asymptomatic for at least 6 weeks following such treatment No CNS metastases No significant ascites, pleural effusion, or pericardial effusion PATIENT CHARACTERISTICS: Age: Adult under 80 (i.e., of legal age to sign own informed consent according to institutional policy) Performance status: Karnofsky 90-100% ECOG 0 Hematopoietic: Granulocytes at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal Renal: Creatinine less than 2.26 mg/dL Cardiovascular: No arrhythmia Other: No infection No other medical condition that is uncontrolled or could be aggravated by the protocol therapy No prior or concurrent second cancer except: Nonmelanomatous skin cancer In situ cervical cancer No pregnant women Adequate contraception required of fertile patients Blood/body fluid analyses to determine eligibility and quality-of-life questionnaire completed within 14 days prior to randomization; imaging studies of sites of disease completed within 28 days prior to randomization PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease or local recurrence Prior fluorouracil-based or other adjuvant therapy allowed At least 6 months required between completion of therapy and documentation of metastasis or recurrence Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed | |
| 19 | NCT00002593 | completed | 0 | phase 3 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['fluorouracil', 'leucovorin calcium', 'levamisole hydrochloride'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1', 'C1CN2C[C@@H](N=C2S1)C1=CC=CC=C1'] | DISEASE CHARACTERISTICS: Histologically proven resectable stage II or III adenocarcinoma of the colon Caudal margin of the primary tumor must lie above the peritoneal reflection Must have pathologic confirmation of either N1-3 (stage III), or if N0, must have T3-T4 (stage II) with bowel obstruction or perforation Obstruction documented as: At least 75% colon or small bowel obstruction on x-ray and/or endoscopy Significant bowel dilatation surgically documented Significant obstruction described in the pathology report Perforation documented by gross operative/pathologic evidence of a colon wall defect with associated abscess or peritonitis Complete en bloc resection by laparotomy required No laparoscopic colectomy without prior surgery on protocol SWOG-9411 No gross or microscopic residual disease No distant peritoneal metastases (stage IV) even if grossly resectable No requirement to open the pelvic peritoneum to define the extent of disease No extrapelvic nodal metastasis unless resected en bloc with the primary tumor No distant metastases No other diagnosis of stage II-III colon cancer within the past 5 years May have undergone complete surgical resection at least 5 years prior to study Completely resected prior or synchronous stage 0-I colon cancer eligible PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Hematopoietic: WBC (white blood cell) at least 3,500/mm3 Platelet count at least within the lower limit of normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST (angiotensin sensitivity test) no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: No organic brain syndrome, Alzheimer's disease, or other altered mental status No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior fluorouracil or other chemotherapy for cancer No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy for cancer Surgery: Complete en bloc resection required (see Disease Characteristics) | |
| 20 | NCT00002597 | completed | 0 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['flutamide', 'zoladex', 'lupron'] | ['CC(C)C(=O)NC1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F', 'CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O'] | Inclusion criteria: - Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b. - Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0). - Karnofsky performance status ≥ 70. - PSA is mandatory, must be ≤ 20) - No prior hormonal therapy, radiation or chemotherapy. - Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization. - Prior testosterone administration allowed if at least 90 days elapsed since last administration. - No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman. - Treatment begins within 21 days after randomization. - Patients signs a study-specific informed consent form. - Alanine Aminotransferase (ALT) within 2x upper normal limits. Exclusion criteria: - Stage T1a or ≥ T2c disease. - Lymph node involvement (N1 - N3). - Evidence of distant metastasis. (M1) - PSA > 20. - Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy. - Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma. Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry. - Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. - Karnofsky performance status of < 70. | |
| 21 | NCT00002623 | completed | 0 | phase 3 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['carboplatin', 'cisplatin'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | DISEASE CHARACTERISTICS: - Histologically or cytologically proven primary unresectable non-small cell lung cancer (NSCLC) by mediastinoscopy, mediastinotomy, thoracotomy, video-assisted thoracic surgery, or needle biopsy - Stage IIIA (N2) disease by chest CT scan - Any histologic subtype allowed - At least 1 unidimensionally or bidimensionally measurable target lesion on chest CT scan - No N3 or metastatic disease by physical exam, CT scan of thorax, bone scan, and CT scan or ultrasound of liver and adrenals - No pre-existing pleural or pericardial effusion - No symptomatic CNS involvement PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No superior vena cava syndrome Pulmonary: - No diffuse interstitial pulmonary fibrosis Other: - No prior melanoma, breast cancer, or hypernephroma - No other primary malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No grade 2 or greater pre-existing motor or sensory neurotoxicity - No active uncontrolled infection requiring IV antibiotics - Must be physically and mentally fit for study therapy - No psychological, familial, sociological, or geographical condition that would preclude study compliance - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for NSCLC Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for NSCLC Surgery: - No prior surgery for NSCLC Other: - No other prior therapy for NSCLC | |
| 22 | NCT00002633 | completed | 1 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['bicalutamide', 'buserelin', 'flutamide', 'goserelin', 'leuprolide acetate', 'nilutamide'] | ['[H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O', 'CC(C)C(=O)NC1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F', 'CC(C)C[C@H](NC(=O)[C@@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=C1C=CC=C2)NC(=O)[C@H](CC1=CNC=N1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O', 'CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O', 'CC1(C)NC(=O)N(C1=O)C1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F'] | DISEASE CHARACTERISTICS: - Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following: - T3-4, N0 or NX, M0 - T2, PSA greater than 40 µg/L - T2, PSA greater than 20 µg/L AND Gleason score at least 8 - Diagnosis made within the past 6 months - Gleason score and PSA known - Pelvic lymph nodes must be clinically negative - Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis - Negative needle aspirate required for any lymph node more than 1.5 cm - If a lymph node dissection was performed, it must be histologically negative - No small cell or transitional cell carcinoma by biopsy - No bony metastases by bone scan PATIENT CHARACTERISTICS: Age: - Under 80 Performance status: - ECOG 0-2 Life expectancy: - At least 5 years excluding malignancy Hematopoietic: - Hemoglobin at least 10.0 g/dL - WBC at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT and SGPT less than 2 times ULN - Alkaline phosphatase less than 2 times ULN - No history of chronic liver disease Renal: - Creatinine less than 2 times ULN Other: - No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability) - No other malignancy within the past 5 years except nonmelanoma skin cancer - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met: - Negative bone scan before beginning any hormonal therapy - Extracapsular extension remains palpable on rectal re-exam - Baseline PSA known before beginning any hormonal therapy - At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy Radiotherapy: - No prior pelvic irradiation Surgery: - No prior radical prostatectomy - Prior transurethral resection of the prostate allowed Other: - No prior cytotoxic anticancer therapy - No other prior treatment for prostate cancer - No other concurrent anticancer therapy unless documented disease progression | |
| 23 | NCT00002635 | completed | 0 | phase 2 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['aminocamptothecin'] | ['CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=C1N=C1C=CC=C(N)C1=C3)C2=O'] | DISEASE CHARACTERISTICS: Histologically confirmed, advanced stages IIB/III/IV cutaneous T-cell lymphoma Measurable or evaluable disease required Measurable disease includes: Skin disease evaluated by clinical assessment grid method Lesion measurable on imaging (i.e., CT measurement of lymph nodes) Pure osteolytic lesion Unidimensional lesion for which a normal measurement is available (e.g., mediastinal width on x-ray) Evaluable disease defined as malignant disease evident on physical or radiographic exam but not measurable by ruler or caliper, i.e.: Pelvic masses Confluent multinodular lung metastases Skin metastases CNS metastases eligible if stable for at least 4 weeks following completion of surgery or radiotherapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No contraindication to indwelling central venous catheter No active infection including HIV No other medical condition that would preclude protocol compliance No pregnant or nursing women Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological therapy allowed Chemotherapy: Prior systemic chemotherapy allowed Patients with more than 1 prior regimen analyzed separately At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: Prior skin irradiation allowed At least 4 weeks since wide-field radiotherapy Surgery: Fully recovered from prior surgery Other: Prior topical therapy allowed Prior PUVA allowed | |
| 24 | NCT00002646 | completed | 0 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['fenretinide', 'tamoxifen citrate'] | ['C\\C(\\C=C\\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(=O)NC1=CC=C(O)C=C1', 'COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC'] | DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Pathologic stage T1-3, N1-2, M0 No clinical or pathologic T4 disease No primary tumor fixed to chest wall No axillary nodes fixed to chest wall or neurovascular bundle No preoperative arm edema No clinical skin involvement (microscopic focal dermal invasion or dermal lymphatic involvement eligible) No clinical N2 disease Modified radical mastectomy or lumpectomy required prior to entry Sentinel node biopsy allowed Randomization required within 12 weeks from definitive surgery Surgery dated from mastectomy or axillary dissection for lumpectomy No positive deep mastectomy margins Radiotherapy planned within 12 weeks following axillary node dissection for lumpectomy patients Synchronous bilateral breast cancer eligible If tumor is at least 2 cm, then nodes not involved If no tumor is at least 2 cm, then at least 1 node must be involved Both invasive primaries receptor-positive Previously treated, noninvasive breast cancer eligible No prior invasive breast cancer No adenoid cystic, squamous, or sarcomatous histology Hormone receptor status: Estrogen- or progesterone-receptor positive, i.e.: At least 10 fmole/mg cytosol protein by ligand-binding assay OR Receptor positive by immunocytochemistry PATIENT CHARACTERISTICS: Age: 65 and over OR Postmenopausal and ineligible/inappropriate for or declined other active node positive adjuvant studies Sex: Female Menopausal status: Postmenopausal, defined as: At least 1 year since last menstrual period Hysterectomized with bilateral oophorectomy Hysterectomized with 1 or both ovaries remaining and either: Over 60 FSH in postmenopausal range Not surgically castrated, under 60, and on HRT FSH elevated 2 weeks after HRT discontinued Performance status: Not specified Life expectancy: At least 7 years except for breast cancer Hematopoietic: WBC greater than 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL BUN no greater than 25.0 mg/dL Other: No extensive macular degeneration on exam within 1 year of entry, e.g.: No exudative or atrophic macular lesions that reduce corrected vision to less than 20/40 Health adequate for protocol treatment No nutritional supplementation except single daily multivitamin No other vitamin A supplements Gynecologic exam within the past year required of women who retain a uterus No second malignancy within the past 10 years except: Inactive nonmelanomatous skin cancer Carcinoma in situ of the cervix Prior noninvasive contralateral breast cancer PRIOR CONCURRENT THERAPY: No prior chemotherapy or hormonal therapy for breast cancer except: Up to 1 month of tamoxifen if started by a non participating physician At least 2 weeks since hormone replacement therapy No concurrent megestrol | |
| 25 | NCT00002684 | completed | 0 | phase 2 | ['bladder cancer', 'urethral cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['cisplatin', 'ifosfamide', 'paclitaxel'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Histologically proven unresectable or metastatic urothelial cancer - No transitional cell histologies - Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count greater than 150,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 55 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - No other concurrent malignancy except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior systemic chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 3 weeks since prior radiotherapy Surgery - Not specified | |
| 26 | NCT00002717 | completed | 0 | phase 3 | ['ovarian cancer', 'primary peritoneal cavity cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['cisplatin', 'paclitaxel'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer or primary peritoneal cancer Suboptimal residual disease within 6 weeks of laparotomy with maximum resection Stage III residual retroperitoneal disease greater than 1 cm and no greater than 1 cm residual intraperitoneal disease OR Stage IV disease The following histologies are eligible: Serous adenocarcinoma Malignant Brenner's tumor Mucinous adenocarcinoma Endometrioid adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Adenocarcinoma not otherwise specified Measurable disease not required Cytologic confirmation of malignant pleural effusion required if sole basis of entry No borderline (low malignant potential) carcinoma No unclassified ovarian cancer, i.e., thought to be of ovarian origin but unexplored or unable to verify tumor arising from ovarian stroma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST, ALT, and GGT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal LDH no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No history of congestive heart failure No history of unstable angina No myocardial infarction within 6 months Other: No severe infection, including septicemia No severe gastrointestinal bleeding No history of second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging laparotomy and primary cytoreductive surgery | |
| 27 | NCT00002735 | terminated | terminated due to poor accrual. | 0 | phase 2 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['induction chemotherapy', 'cisplatin', 'fluorouracil'] | ['CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the hypopharynx or base of the tongue that is newly diagnosed and considered resectable For hypopharyngeal cancer, total laryngectomy would be required surgery Disease staged by clinical exam, endoscopy, and CT or MRI Stage III that is T2-3 N0-1 M0 Stage IV that is T2-3 N2-3 M0 Measurable or evaluable disease other than pleural effusion, ascites, or disease documented by indirect evidence Closed to patients with cancer of the base of tongue as of 11/15/1998 PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST or ALT no greater than 3 times normal Renal: Creatinine no greater than 2 times normal Creatinine clearance at least 60 mL/min Magnesium normal (supplementation allowed) Other: Average hearing loss in both ears no greater than 40 dB in 50-2,000 Hz range No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix Stage I/II cancer (other than head/neck) in complete remission Not pregnant or nursing Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: No prior therapy |
| 28 | NCT00002764 | completed | 0 | phase 3 | ['endometrial cancer', 'kidney cancer', 'metastatic cancer', 'ovarian cancer', 'pheochromocytoma', 'sarcoma'] | ["['N85.00', 'N85.01', 'N85.02', 'N99.85']", "['D17.71', 'D30.00', 'D30.01', 'D30.02', 'D41.00', 'D41.01', 'D41.02']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['doxorubicin hydrochloride', 'ifosfamide'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma with pulmonary metastases for which radical metastasectomy is feasible Eligible subtypes: Malignant fibrous histiocytoma Liposarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Neurogenic sarcoma Unclassified sarcoma Angiosarcoma (including hemangiopericytoma) Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus) Ineligible subtypes: Alveolar rhabdomyosarcoma Kaposi's sarcoma Rhabdomyosarcoma of any type Malignant mesothelioma Chondrosarcoma Neuroblastoma Dermatofibrosarcoma Osteosarcoma Epithelioid sarcoma Primitive neuroectodermal tumor Ewing's sarcoma No extrapulmonary disease Previously treated local recurrence allowed Patients with primarily metastatic disease must have undergone radical treatment of primary tumor according to local protocols Reevaluation of metastases required before randomization PATIENT CHARACTERISTICS: Age: 16 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 1.25 times normal Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of cardiovascular disease Other: No other severe medical illness (including psychosis) No prior or concurrent other primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior neoadjuvant or adjuvant chemotherapy for primary soft tissue sarcoma allowed if cumulative dose of doxorubicin no greater than 200 mg/m2 At least 1 year since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics | |
| 29 | NCT00002772 | terminated | poor accrual | 0 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['carboplatin', 'carmustine', 'cisplatin', 'cyclophosphamide', 'doxorubicin hydrochloride', 'paclitaxel', 'tamoxifen citrate', 'thiotepa'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'ClCCNC(=O)N(CCCl)N=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', 'COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC', 'CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1'] | DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with at least 4 involved axillary and/or intramammary lymph nodes No known T4, N3, or M1 disease Dermal lymphatic involvement without clinical inflammatory changes (edema, peau d'orange, erythema) allowed Must have undergone breast conserving surgery or modified radical mastectomy plus axillary lymph node dissection Surgical margins negative for invasive or noninvasive ductal carcinoma At least 10 nodes sampled No more than 12 weeks since definitive surgery Synchronous bilateral breast carcinoma allowed if: Diagnosed within 4 weeks of initial histologic diagnosis One breast meets the eligibility criteria Other breast has fewer than 10 involved nodes and is not N3 or T4 Both breasts treated by modified radical mastectomy or breast conserving surgery with axillary node dissection Concurrent registration on S9719 Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Any status Performance status: SWOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Hepatitis C status required Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at rest at least 45% by MUGA No EKG abnormalities unless cleared by a cardiologist No uncontrolled or significant cardiac disease No congestive heart failure No second or third degree heart block or other serious cardiac conduction abnormality No atrial or ventricular arrhythmia No requirement for medication known to affect cardiac conduction unless: Given for reasons other than heart failure or arrhythmia Cleared by a cardiologist Pulmonary: FVC and FEV1 at least 60% predicted DLCO at least 60% predicted Other: HIV negative Hepatitis B surface antigen status required No serious medical or psychiatric illness that would preclude informed consent or study participation No second malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma of the breast (diagnosed at any time) Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy for breast cancer Radiotherapy: No prior radiotherapy to the breast Surgery: See Disease Characteristics |
| 30 | NCT00002790 | withdrawn | 0 | phase 1/phase 2 | ['graft versus host disease', 'leukemia', 'myelodysplastic syndromes'] | ["['D89.810', 'D89.811', 'D89.813', 'D89.812']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['D46.9', 'D46.C', 'D46.Z']"] | ['cyclosporine', 'methotrexate', 'sirolimus'] | ['CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', 'CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2'] | DISEASE CHARACTERISTICS: See General Eligibility Criteria PATIENT CHARACTERISTICS: Age: 13 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac disease No clinically significant cardiac abnormality No ischemia No recent injury on EKG Other: No intolerance or unresponsiveness to rapamycin No hypersensitivity to macrolide antibiotics, e.g., erythromycin, azithromycin, clarithromycin No requirement for medications that may significantly affect rapamycin metabolism, i.e.: Carbamazepine Ketoconazole Primidone Cimetidine Nicardipine Rifampin Diltiazem Phenobarbital Valproic acid Erythromycin Phenytoin Verapamil No uncontrolled systemic infection No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients during and for 3 months after study Able to tolerate less than 400 mL of liquid oral intake PRIOR CONCURRENT THERAPY: At least 1 week since any investigational drug | |
| 31 | NCT00002819 | terminated | 0 | phase 3 | ['ovarian cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['carboplatin', 'cyclophosphamide', 'mitoxantrone hydrochloride', 'paclitaxel'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial carcinoma including the following cellular diagnoses: Serous adenocarcinoma Mucinous adenocarcinoma Endometrioid adenocarcinoma Clear cell adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Stage III (optimal or suboptimal) must be surgically reassessed OR Stage III (suboptimal) or stage IV clinically reassessed after induction chemotherapy For stage III surgical reassessment: No more than 12 weeks between end of chemotherapy and reassessment surgery AND No more than 6 weeks between reassessment surgery and randomization Patients treated on protocol GOG-158 are eligible At least a partial response to chemotherapy as defined as: Microscopic disease documented at reassessment surgery for patients optimally debulked (disease no greater than 1 cm) after primary surgery Suboptimally debulked disease (greater than 1 cm) after primary surgery and 1 of the following: Negative reassessment laparotomy Only microscopic disease at reassessment surgery Gross residual disease no greater than 1 cm at reassessment surgery prior to debulking Clinical complete response to induction chemotherapy including: - suboptimal disease Stage III or IV AND - either an abnormal CT or elevated CA-125 prior to induction chemotherapy and both are within normal limits following induction chemotherapy PATIENT CHARACTERISTICS: Age: Under 66 Performance status: GOG 0 or 1 Hematopoietic: Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% by MUGA No congestive heart failure Pulmonary: FEV1 and FVC at least 60% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy in the past 5 years except adequately treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or any other cancer whose prior treatment does not contraindicate this study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 and no more than 6 prior platinum-based combination chemotherapy courses (i.e., cisplatin or carboplatin) required Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior anthracyclines | |
| 32 | NCT00002863 | terminated | insufficient accrual | 0 | phase 1 | ['sarcoma'] | ["['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['chemotherapy'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | DISEASE CHARACTERISTICS: Biopsy-proven soft tissue sarcoma (STS) of the extremity Review by Pathology Department of the University of Southern California CT or MRI required prior to biopsy Disease in one of the following categories: High-grade tumor Low-grade tumor at high risk for local recurrence, i.e.: Adjacent to bone or vital neurovascular structures and able to be removed with a minimal surgical margin (i.e., plane of dissection goes through reactive zone of tumor) Lesion more than 5 cm in diameter The following tumors exclude: Primary sarcoma of the bone Metastatic carcinoma STS of the head and neck Visceral STS, e.g., breast, uterus, spermatic cord, mediastinum chest wall STS of the pelvis or retroperitoneum PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hemoglobin at least 9 g/Dl Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times normal Renal: Not specified Other: No concurrent disease that renders patient medically or psychologically unable to tolerate treatment PRIOR CONCURRENT THERAPY: At least 30 days since therapy for sarcoma |
| 33 | NCT00002864 | completed | 0 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['octreotide acetate', 'tamoxifen citrate'] | ['[H][C@]1(NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CSSC[C@H](NC1=O)C(=O)N[C@H](CO)[C@@H](C)O)NC(=O)[C@H](N)CC1=CC=CC=C1)[C@@H](C)O', 'COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC'] | DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast that is potentially curable Prior treatment with one of the following therapies required: Segmental mastectomy (lumpectomy) followed by radiotherapy Chest wall irradiation allowed only in patients with T4 dermal involvement on pathologic diagnosis Further excision or boost radiotherapy to the tumor bed recommended if microscopic disease found at mastectomy margins Total mastectomy Chest wall irradiation required if microscopic disease found at mastectomy margins Clinical stage T1-3a N0-2 M0 disease prior to surgery The following T4 features exclude: Chest wall extension Edema (including peau d'orange) Skin ulceration Satellite skin nodules confined to same breast Inflammatory carcinoma Pathologic stage T1-4 NX-2 M0 disease following surgery Eligible T4 tumors are those with dermal involvement on pathology assessment only Pathologic assessment of axillary lymph nodes required May be omitted in patients with clinical N0 status provided other entry criteria are met No bilateral breast cancer without complete resection of both sides Hormone receptor status: Estrogen and progesterone receptor status determined from primary tumor when possible by quantitative biochemical methods or immunohistochemistry Results recorded as positive or negative if immunohistochemistry used Unknown status does not exclude provided other entry criteria are met PATIENT CHARACTERISTICS: Age: Postmenopausal Sex: Women only Menopausal status: Postmenopausal by one or more of the following: Amenorrhea lasting more than 1 year in women under 50 years of age with no prior hysterectomy No menses for 6 months prior to breast surgery in women 50 years of age and over with no prior hysterectomy Documented oophorectomy prior to breast cancer diagnosis Luteinizing hormone and follicle-stimulating hormone values diagnostic of postmenopausal status by local laboratory criteria Women 50 years of age and over with prior hysterectomy Performance status: ECOG 0-2 Life expectancy: At least 5 years Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: (unless metastatic disease ruled out by radiologic exam) AST or ALT less than twice normal Alkaline phosphatase less than twice normal Renal: Not specified Other: No symptomatic gallbladder disease or cholecystitis No intercurrent illness that reduces life expectancy to less than 5 years No other major medical or psychiatric illness that precludes study treatment or follow-up No second malignancy within 5 years except: Adequately treated basal cell skin carcinoma Adequately treated cancer of the cervix, endometrium, colon, or thyroid Able and willing to complete quality-of-life questionnaires in English or French Illiteracy, loss of sight, or other inability to complete questionnaires does not exclude Accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: Prior or concurrent adjuvant chemotherapy allowed at investigator's discretion Recommended regimens: CMF (cyclophosphamide/methotrexate/fluorouracil) CEF (cyclophosphamide/etoposide/fluorouracil) AC (doxorubicin/cyclophosphamide) Choice of adjuvant chemotherapy regimen defined prior to randomization if given concurrently with protocol therapy Endocrine therapy: No estrogen, progestins, or androgen therapy for a period of more than 30 days following pathologic diagnosis of breast cancer Prior tamoxifen allowed All hormonal therapy discontinued prior to randomization Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics | |
| 34 | NCT00002868 | completed | 0 | phase 3 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['busulfan', 'cytarabine', 'etoposide', 'hydroxyurea', 'idarubicin'] | ['CS(=O)(=O)OCCCCOS(C)(=O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'NC(=O)NO', '[H][C@@]12C[C@H](N(C(=O)[C@H](C)N[C@@H](CCC3=CC=CC=C3)C(=O)OCC)[C@@]1([H])CCCC2)C(O)=O'] | DISEASE CHARACTERISTICS: Newly diagnosed chronic myelogenous leukemia in chronic phase Philadelphia chromosome and/or BCR/ABL positive Initial diagnosis within 6 months of randomization No clinical or laboratory evidence of acceleration or blastic disease No contraindication to peripheral blood cell stem cell collection prior to treatment PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No major organ impairment Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon alfa Chemotherapy: Prior hydroxyurea allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified | |
| 35 | NCT00002869 | unknown status | 0 | phase 3 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['cytarabine', 'hydroxyurea'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'NC(=O)NO'] | DISEASE CHARACTERISTICS: Chronic myelogenous leukemia in chronic phase Molecular evidence of BCR/ABL rearrangement OR Presence of Philadelphia chromosome Eligibility for allogeneic bone marrow transplantation does not exclude PATIENT CHARACTERISTICS: Age: Adult Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Bilirubin less than twice normal No severe hepatic problem Renal: Creatinine less than twice normal No severe renal problem Cardiovascular: No severe cardiovascular problem Other: No contraindication to interferon therapy No history of severe depression No pregnant women Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: No prior therapy Prior therapeutic or back-up leukapheresis allowed Hydroxyurea may be started up to 4 weeks prior to entry | |
| 36 | NCT00002874 | unknown status | 1 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['bicalutamide', 'placebo'] | ['[H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Conditions for Patient Eligibility: - The patient on entry will have no clinical evidence of disease by physical exam or by imaging studies. A positive ProstaScint scan alone without a confirmatory biopsy must not be used to exclude a patient. Eligible patients will be those who have undergone a radical prostatectomy (either retropubic or perineal) and pelvic lymphadenectomy (either open or laparoscopic) for carcinoma of the prostate, pathologic stage T3N0, or pT2 pN0 with positive inked resection margin, at least 12 weeks prior to study entry. - Pathological T2 patients without positive margins, who are also pathologic N0 with prostatic fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer, are eligible. - At entry, the PSA must be between 0.2 and 4.0ng/ml, inclusive. - A post-prostatectomy radioisotopic bone scan which was done within 16 weeks prior to entry must reveal no evidence of metastatic disease. - Patient must be evaluated by both the radiation oncologist and the urologist prior to entry and judged to be a suitable candidate for radiation and hormonal therapy. - Patient must have Karnofsky performance status >= 80. - Patients must have a life expectancy in excess of 10 years. - Patients must have, within 6 weeks prior to entry, a hemoglobin (Hgb) of >=10 gm, a white blood cell (WBC) count of >= 4000 cells/ml3, a platelet count of >= 100,000 cells/ml3, a serum bilirubin <= the institutional upper limit of normal, a serum serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) of <= 2.5 times the institutional upper limit of normal, and a serum creatinine of <= 2.0 times the institutional upper limit of normal. - A post-prostatectomy pelvic computerized tomography (CT) scan, within 16 weeks prior to randomization, must reveal no evidence of metastatic disease. - Patients must sign a study-specific informed consent form. - Patients with prior invasive cancers are eligible if disease free for at least 5 years; prior or concurrent basal or squamous cell skin cancer is eligible. Conditions for Patient Ineligibility: - Pathologic stage T2 (without positive inked resection margin) or less except as stated in Section 3.1.1.1. - Pathologic lymph node stage of pN1 or greater. - An entry serum PSA of > 4.0ng/ml. - Patients with persistant urinary extravasation after prostatectomy. - Patients who have been previously treated with any hormonal therapy after prostatectomy. - Patients who have previously been treated with radiation therapy or biologic therapy for prostate cancer. - Karnofsky performance status < 80. - Treatment start > 4 weeks after randomization. - Prior chemotherapy for any reason. | |
| 37 | NCT00002878 | completed | 0 | phase 3 | ['multiple myeloma and plasma cell neoplasm'] | ["['C96.20', 'C96.29', 'D47.09']"] | ['dexamethasone', 'doxorubicin hydrochloride', 'valspodar', 'vincristine sulfate'] | ['C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'C\\C=C\\C[C@@H](C)C(=O)[C@@H]1N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C(=O)[C@@H](NC1=O)C(C)C)C(C)C', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: - Multiple myeloma of any stage confirmed by: - Bone marrow plasmacytosis with at least 10% plasma cells, sheets of plasma cells, or biopsy proven plasmacytosis - Myeloma (M) protein in serum and/or urine - Measurable disease by at least one of the following: - Serum M-component at least 1.0 g/dL by electrophoresis - Baseline measurement by nephelometry also, if used to follow response - Urine M-protein excretion greater than 200 mg/24 hours by electrophoresis - The following are not considered measurable but are followed for response: - Lytic bone lesions - Bone marrow plasmacytosis - Anemia - Serum beta 2-microglobulin - Objective evidence of progression by at least one of the following: - Increased serum M-protein (by electrophoresis unless M-spike less than 1.5 g/dL) - At least 50% above lowest remission level or by at least 2 g/dL - To more than 1.0 g/dL if sole protein indication of relapse - Nephelometry may be used instead of electrophoresis - Increased urine M-protein - To 50% above lowest level OR by 2 g/24 hours - To greater than 200 mg/24 hours - Definite new lytic bone lesions or at least a 50% increase in size of existing lesions (discussion with ECOG Study Chairman required if sole indication of progression) - Increase in serum or urine M-protein by 25% to under 50% (as above) plus one of the following: - Serum calcium greater than 12 mg/dL without other cause - Hemoglobin decreased by more than 2.0 g/dL not attributed to chemotherapy, interferon therapy, or a myelodysplastic syndrome - Less than 11 g/dL in men - Less than 10 g/dL in women - At least a 50% increase in bone marrow plasmacytosis - Failure of prior cytotoxic therapy defined by one of the following: - Never responded - Relapsed within 2 months of last treatment - Relapsed 2-12 months after last treatment following initial response - Adequate prior chemotherapy required, e.g.: - At least 2 courses of combination chemotherapy (e.g., VBMCP, VBAP, MP) - Prior vincristine, doxorubicin, and dexamethasone (VAD) allowed - No demonstrated resistance to VAD - At least 3 months since prior VAD - Cumulative doxorubicin dose no more than 250 mg/m2 - Prior autologous peripheral blood stem cell transplant allowed if performed prior to development of drug resistance - No prior allogeneic transplant - No smoldering myeloma, localized plasmacytoma, or monoclonal gammopathy of undetermined significance (MGUS) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-3 Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST less than 1.5 times ULN - No chronic or active hepatitis or cirrhosis Renal: - Creatinine less than 3.0 mg/dL Cardiovascular: - Ejection fraction at least 50% - No history of congestive heart failure - No overt angina despite medication - No myocardial infarction within 2 months - No poorly controlled hypertension (i.e., pressure 200/110 or higher despite medication) - No arrhythmia requiring therapy (i.e., sustained atrial or ventricular arrhythmia or multifocal premature ventricular contraction) - Digoxin to control ventricular rate of atrial fibrillation that has been chronic for more than 1 month allowed Neurologic: - No peripheral neuropathy with weakness - No cerebellar disease with ataxia Gastrointestinal: - Adequate gastrointestinal function to allow absorption of PSC 833 - No active peptic ulcer Other: - No hypersensitivity to PSC 833 or cyclosporine - No active infection - HIV negative - No uncontrolled diabetes mellitus - No second malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other localized cancer treated with surgery alone - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other serious medical problem unless sufficiently stabilized PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy (e.g., interferon) allowed Chemotherapy: - See Disease Characteristics - At least 3 weeks since other prior chemotherapy (including plicamycin) Endocrine therapy: - At least 2 weeks since high dose steroids (at least 100 mg/m2/day of prednisone or at least 40 mg/day of dexamethasone (including steroids for hypercalcemia) Radiotherapy: - At least 2 weeks since prior radiotherapy except limited radiotherapy to a single bone lesion Surgery: - At least 4 weeks since prior major surgery Other: - No concurrent anticoagulants - No concurrent drugs known to modulate cyclosporine blood concentrations | |
| 38 | NCT00002882 | completed | 0 | phase 3 | ['melanoma', 'skin cancer'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']", "['C79.2', 'C44.500', 'C44.90', 'D23.9', 'D48.5', 'C44.00', 'C44.301']"] | ['cisplatin', 'dacarbazine', 'vinblastine'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'N1C=CN=C1', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: - Histologically diagnosed malignant melanoma with regional lymph node metastases - Undergone complete lymph node dissection and free of any residual tumor - No greater than 90 days from diagnosis of regional lymph nodes metastases - No distant or resected in-transit metastases PATIENT CHARACTERISTICS: Age: - 10 to 66 - 66 to 70 if in excellent physical condition Performance status: - 0-2 Life expectancy: - At least 12 months Hematopoietic: - Hemoglobin greater than 10 g/dL - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.2 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL Other: - No serious intercurrent illness that would compromise tolerance of therapy and long term survival - Must be able to participate in follow up for minimum of 5 years - No second malignancy except: - In situ cervical cancer - Basal or squamous skin cancer - Must be able to physically and emotionally tolerate biochemotherapy - No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy with interferon or IL-2 - No concurrent immunomodulators Chemotherapy: - No prior chemotherapy Endocrine therapy: - No concurrent steroids Radiotherapy: - Prior adjuvant local radiotherapy allowed for head and neck Surgery: - No greater than 8 weeks after definitive surgery for lymph node metastases Other: - No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase inhibitors | |
| 39 | NCT00002895 | completed | 0 | phase 3 | ['fallopian tube cancer', 'ovarian cancer', 'primary peritoneal cavity cancer'] | ["['C57.00', 'C57.01', 'C57.02']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['chemotherapy'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer - Achieved complete remission with normal CA 125 after first-line platinum-containing chemotherapy - Prior participation in the following clinical trials is allowed: - MRC-ICON2 (carboplatin vs cyclophosphamide, doxorubicin, and cisplatin for advanced disease) - MRC-ICON3 (paclitaxel with carboplatin in first-line therapy for advanced disease) - MRC-ICON5 (carboplatin and paclitaxel vs triplet and sequential doublet combinations of chemotherapy) - No prior participation in MRC-ICON1 (adjuvant chemotherapy for early-stage ovarian cancer) PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No prior or concurrent malignancy within the past 5 years that is likely to preclude study treatment or comparisons except for nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified | |
| 40 | NCT00002911 | completed | 0 | phase 3 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['marimastat'] | ['CNC(=O)[C@@H](NC(=O)[C@H](CC(C)C)[C@H](O)C(=O)NO)C(C)(C)C'] | DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IIIA/B disease No malignant pleural effusions Minimal residual disease after one or a combination of the following: Incomplete surgical resection i.e., macroscopic residual disease at completion of surgery Radical radiotherapy with no evidence of disease progression at entry Documented complete or partial tumor response following at least 2 courses of cytotoxic chemotherapy No evidence of disease progression during or following prior therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: Absolute neutrophil count greater than 500/mm3 Platelet count greater than 50,000/mm3 Hepatic: Bilirubin less than 2.0 times upper limit of normal (ULN) AST/ALT no greater than 3.0 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No acute illness within 1 week of start of study No other illness that would significantly interfere with study outcome No major medical illness that precludes prolonged marimastat administration No second malignancy within 5 years except: Adequately treated basal cell carcinoma of the skin In situ carcinoma of the cervix Not pregnant or nursing Medically approved method of contraception required of fertile women Willing and able to tolerate and comply with study requirements PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior marimastat, batimastat, bleomycin, or busulphan No more than 1 cytotoxic chemotherapy regimen for non-small cell lung cancer Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: At least 4 weeks since any investigational drug therapies | |
| 41 | NCT00002922 | completed | 0 | phase 2 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['paclitaxel'] | ['[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck (including nasopharynx) that is considered incurable with surgery or radiation therapy Bidimensionally measurable disease Patients whose only site of measurable disease is within a previous radiation port must have documented progressive disease or biopsy-proven recurrence after the completion of radiotherapy No uncontrolled CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No history of ventricular arrhythmias or symptomatic bradyarrhythmia Other: No significant detectable infection Not pregnant or nursing No other active malignancies Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interleukin-2, interferons, and monoclonal antibodies allowed Recovered from prior therapy Chemotherapy: Prior paclitaxel infusion no greater than 24 hours for recurrent or metastatic disease required Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Recovered from any prior major surgery | |
| 42 | NCT00002961 | terminated | poor accrual | 0 | phase 3 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['cyclophosphamide', 'cyclosporine', 'etoposide', 'methotrexate', 'busulfan', 'mesna'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', 'CS(=O)(=O)OCCCCOS(C)(=O)=O', 'OS(=O)(=O)CCS'] | DISEASE CHARACTERISTICS: Histologically confirmed childhood acute lymphoblastic leukemia (ALL) in second hematologic remission or greater who have relapsed: On therapy OR Within one year of discontinuation of therapy OR Greater than 1 year from discontinuation of high risk intensive therapy (matched sibling donor only) Patients with central nervous system or testicular relapse: Occurred within 18 months of diagnosis OR Following prophylactic or therapeutic cranial irradiation T cell disease with isolated central nervous system (CNS) or bone marrow relapse at any time Patients in first remission with greater than 4 weeks to achieve remission or with high risk features such as: t(4,11) t(9,22) Hypodiploidy Patients under 12 months of age in first remission with any of the following features at diagnosis: CALLA (CD10) negative white blood count (WBC) at least 100,000/mm3 Day 14 M2 or M3 bone marrow CNS disease PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No active hepatitis B or C Bilirubin no greater than 1.5 times normal Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance at least 65 mL/min Cardiovascular: Shortening fraction greater than 27% by echocardiogram OR Ejection fraction greater than 47% by radionuclide angiogram Pulmonary: [1] forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) greater than 60% For uncooperative children: No evidence of dyspnea at rest No exercise intolerance Pulse oximetry greater than 94% Other: No active infection No occult untreated infection HIV negative Not eligible for Children's Cancer Group (CCG) or Pediatric Oncology Group (POG) transplant study Donor criteria: Genotypically matched sibling or phenotypically matched family member (bone marrow or peripheral blood stem cells may be used) One antigen mismatched related donor Matched or one antigen mismatched unrelated donor Cord blood (genotypic or phenotypic match or one antigen mismatch) Matched sibling or phenotypically matched family member peripheral stem cells PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified |
| 43 | NCT00002967 | completed | 0 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['cyclophosphamide', 'doxorubicin hydrochloride', 'octreotide pamoate', 'tamoxifen citrate'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@]1(NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CSSC[C@H](NC1=O)C(=O)N[C@H](CO)[C@@H](C)O)NC(=O)[C@H](N)CC1=CC=CC=C1)[C@@H](C)O', 'COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC'] | DISEASE CHARACTERISTICS: Histologically confirmed Stage I, IIA or IIB invasive adenocarcinoma of the breast with T1-3, pN0 and M0 classification Must have undergone total mastectomy or lumpectomy followed by an axillary dissection or sentinel node resection if participating in NSABP B-32 Histologically negative axillary lymph nodes OR Histologically negative sentinel lymph nodes if participating in NSABP B-32 Lumpectomy and axillary dissection acceptable only if margins of resected specimen are histologically free of invasive tumor or ductal carcinoma in situ and other dominant masses within the ipsilateral breast remnant are histologically confirmed to be benign Additional operation after resection is allowed in order to obtain clear margins No bilateral malignancy of the breast ER positive tumors as defined by at least one of the following: At least 10 fmol/mg cytosol protein by either dextran-coated charcoal or sucrose density gradient methods Positive or not definitely negative results by the enzyme immunoassay method (EIA) or by immunocytochemical assay No more than 63 days from time of initial cytologic or histologic diagnosis of breast cancer till randomization No bone metastases (confirmation must be made for those with skeletal pain) Tumor must be no greater than 5 cm in its greatest dimension for patients who are treated by lumpectomy and axillary dissection Hormone receptor status: Estrogen receptor positive PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified Life expectancy: At least 10 years (excluding diagnosis of cancer) Performance status: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count postoperative at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT normal Renal: Creatinine normal Cardiovascular: No cardiac disease that would preclude the use of doxorubicin (for patients who are to receive adjuvant chemotherapy in this study), including: Myocardial infarction Angina pectoris that requires antianginal medication History of congestive heart failure Arrhythmia associated with concurrent heart failure or cardiac dysfunction Valvular disease with cardiac compromise Cardiomegaly or ventricular hypertrophy unless left ventricular function is within normal limits Poorly controlled hypertension Other: No prior invasive breast cancer or ductal carcimoma in situ No systemic disease that would preclude patients from any part of study No history of symptomatic gallbladder or biliary tract disease unless patient has undergone cholecystectomy No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude No prior nonbreast malignancies in past 10 years except: Squamous or basal cell carcinoma of the skin that has been effectively treated Carcinoma in situ of the cervix that has been treated by operation only Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmented resection only No psychiatric or addictive disorders Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer No prior anthracycline therapy for patients who are to receive adjuvant chemotherapy in this study Endocrine therapy: No prior endocrine therapy for breast cancer Must discontinue any sex hormonal therapy before prior to and during study Radiotherapy: No prior radiotherapy for breast cancer No breast radiation therapy before randomization for patients who receive lumpectomy Surgery: See Disease Characteristics At least 2 weeks since last surgical procedure Other: No concurrent cyclosporine therapy No concurrent heparin or warfarin anticoagulation therapy | |
| 44 | NCT00002972 | completed | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['paclitaxel'] | ['[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Histologically proven bronchoalveolar carcinoma (BAC) based on these criteria: - Absence of primary adenocarcinoma elsewhere - Absence of a demonstrable central bronchogenic origin - A peripheral location in the lung parenchyma - Intact interstitial framework of the lung - A histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture - Must be unresectable Stage IIIB, IV, or recurrent BAC - Evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe) - At least one target lesion bidimensionally measurable that has not undergone prior irradiation - No CNS disease PATIENT CHARACTERISTICS: Age: - 18 to 75 (inclusive) Performance status: - ECOG 0-2 Life expectancy: - Greater than 3 months Hematopoietic: - ANC at least 1,500/mm^3 Hepatic: - Bilirubin less than 2 times upper limit of normal - SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal Renal: - Creatinine less than 1.5 times upper limit of normal Cardiovascular: - No history of ischemic or congestive heart disease - No arrhythmia requiring chronic cardiopulmonary medications - No history of clinically or electrographically documented myocardial infarction Other: - No preexisting motor or other serious sensory neurotoxicity - No active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix - No clinical evidence of uncontrolled infection - Not pregnant or nursing - Negative pregnancy test 72 hours prior to start of study medication - Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since radiotherapy - Must have at least one bidimensional lesion outside the irradiated fields Surgery: - Fully recovered from any prior major surgery | |
| 45 | NCT00002976 | terminated | 0 | phase 3 | ['endometrial cancer'] | ["['N85.00', 'N85.01', 'N85.02', 'N99.85']"] | ['conjugated estrogens'] | ['[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3'] | DISEASE CHARACTERISTICS: - Histologically confirmed grade I, II or III endometrial adenocarcinoma (endometrioid, villoglandular, mucinous, adenosquamous, papillary serous, clear cell, or not otherwise specified) - Must have had total hysterectomy and bilateral salpingo-oophorectomy within past 20 weeks - Surgical stage IA, IB, IC, IIA (occult), or IIB (occult) disease - Must have had normal mammogram, or a negative breast biopsy after an abnormal mammogram, within past year PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT no greater than 3 times normal - No acute liver disease Renal: - Not specified Cardiovascular: - No prior thromboembolic disease Other: - No prior or current carcinoma of the breast - No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No concurrent hormonal therapy Radiotherapy: - Not specified Surgery: - See Disease Characteristics - Recovered from prior surgery Other: - No prior cancer treatment that would preclude study therapy - Concurrent participation on GOG Lap-1 or GOG Lap-2 allowed | |
| 46 | NCT00003005 | completed | 0 | phase 1 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['cordycepin', 'deoxycoformycin'] | ['[H][C@@]1(CO)C[C@@]([H])(O)[C@@]([H])(O1)N1C=NC2=C(N)N=CN=C12', 'OC[C@H]1O[C@H](C[C@@H]1O)N1C=NC2=C1N=CNC[C@H]2O'] | DISEASE CHARACTERISTICS: TdT positive acute lymphocytic leukemia or blastic chronic myelogenous leukemia Failed at least one standard treatment PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky greater than 70% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection fraction greater than 40% Other: Not pregnant or nursing No serious concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since radiation therapy Surgery: Not specified | |
| 47 | NCT00003034 | unknown status | 1 | phase 3 | ['malignant mesothelioma'] | ["['C45.9', 'C45.0', 'C45.1', 'C45.2', 'C45.7']"] | ['doxorubicin hydrochloride', 'ranpirnase'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed malignant pleural or peritoneal mesothelioma - Measurable or evaluable disease - CALGB groups 1-4 - No CNS metastases PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - SGOT no greater than 2 times upper limit of normal - Bilirubin no greater than 2 mg/dL - PT and PTT normal Renal: - Creatinine normal Cardiovascular: - No symptomatic New York Heart Association class II-IV cardiovascular disease - No congestive heart failure - No angina pectoris - No cardiac arrhythmias - No uncontrolled hypertension - No cerebrovascular disease Metabolic: - No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious infection - No uncontrolled psychosis or neurologic disease (e.g., seizure disorders) - No uncontrolled diabetes mellitus - No other primary malignancy within the past 5 years except nonmelanoma skin cancer - No senility or emotional instability PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than one prior systemic chemotherapy regimen - No prior doxorubicin - At least 6 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy Surgery: - Prior surgical resection allowed | |
| 48 | NCT00003041 | completed | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['pyrazoloacridine'] | ['NC(=O)C1=NC=CN=C1'] | DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally measurable disease of any of the following types required: Bidimensionally measurable lung lesions on chest X-ray, CT scan, or MRI Palpable and quantifiable lymph nodes at least 2 x 2 cm Abdominal mass at least 2 x 2 cm quantifiable by CT scan Bidimensionally measurable liver metastases at least 2 x 2 cm Palpable hepatomegaly if liver edge is clearly defined and extends at least 5 cm below the costal margin of the xiphoid process Unacceptable as measurable disease: Diffuse lung infiltration or unidimensionally measurable hilar lesions Pelvic mass of indefinite dimension Bone metastases Pleural effusion or ascites No brain metastases Must have failed or progressed on prior therapy or relapsed less than 12 months after therapy discontinuation Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 16 and over Sex: Female Menopausal status: Not specified Performance status: SWOG 0-2 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of congestive heart failure, myocardial infarction within past 6 months, ventricular arrhythmia, or ischemic heart disease requiring medication If necessary, ejection fraction at least 50% by MUGA Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior malignancies in past 5 years other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No other serious illnesses or active infections No seizure disorder requiring anticonvulsant therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens for metastatic disease One prior adjuvant chemotherapy regimen for metastatic disease allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: One prior regimen of hormonal therapy for metastatic disease allowed At least 3 weeks since prior hormonal therapy and recovered No concurrent hormonal or corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: At least 4 weeks since any prior treatment directed at the tumor and recovered No other concurrent anticancer or investigational therapy No concurrent participation on another therapeutic clinical trial | |
| 49 | NCT00003052 | completed | 1 | phase 3 | ['sarcoma'] | ["['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['doxorubicin hydrochloride', 'etoposide', 'ifosfamide'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: - Histologically proven grade II or III soft tissue sarcoma of one of following high-risk groups: - Grade II/III primary tumor with lesion size of at least 5 cm, deep, and extracompartmental (S1) - Local recurrence of primary tumor (S2) - Inadequate surgical excision of S1 or S2 (S3) - Disease recurrence after prior surgery allowed - The following histological types are eligible: - Malignant fibrous histiocytoma - Liposarcoma (round cell and pleomorphic) - Leiomyosarcoma - Fibrosarcoma - Rhabdomyosarcoma - Synovial sarcoma - Malignant paraganglioma - Neurofibrosarcoma (malignant schwannoma) - Extraskeletal Ewing's sarcoma - Extraskeletal osteosarcoma - Malignant peripheral neuroectodermal tumors - Mesenchymal chondrosarcoma - Angiosarcoma - Miscellaneous sarcoma - Unclassified sarcoma - No distant metastases PATIENT CHARACTERISTICS: Age: - 18 to 70 Performance status: - WHO 0-2 OR - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding disorder Hepatic: - Bilirubin less than 1.25 times upper limit of normal - No severe hepatic dysfunction Renal: - Creatinine clearance greater than 60 mL/min - No chronic renal failure Cardiovascular: - No documented existing cardiac failure - No manifest heart failure (New York Heart Association class III or IV) - Left ventricular ejection fraction no more than 10% below institutional normal Other: - No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No other severe disease - No severe cerebrovascular disease - No extremely obese patients - No prior metallic implants relevant to the regional hyperthermia field - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy (except to disease recurrence outside study irradiation field) Surgery: - See Disease Characteristics - No prior mutilative surgery | |
| 50 | NCT00003060 | terminated | lack of patient accrual | 0 | phase 1 | ['melanoma (skin)'] | ["['C43.51', 'C43.9', 'C43.52', 'D03.51', 'C43.8', 'Z85.820', 'D03.52']"] | ['busulfan', 'cyclophosphamide', 'cyclosporine', 'methotrexate'] | ['CS(=O)(=O)OCCCCOS(C)(=O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O'] | DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor (5- or 6-antigen match) No history of CNS metastases PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1 greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO greater than 50% predicted Other: Not pregnant Fertile women must use effective contraception HIV negative No active bacterial, fungal, or viral infection Hepatitis B negative PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease |
| 51 | NCT00003062 | completed | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['temozolomide'] | ['CSCC[C@H](N)C(O)=O'] | DISEASE CHARACTERISTICS: Histologically confirmed progressive or recurrent stage IV non-small cell lung cancer (NSCLC) Patient with brain metastases on CT or MRI scan are included Symptomatic cases must have had brain radiotherapy at least one month prior to registration Patients without brain metastases: At least one target lesion Bidimensionally measurable Not previously irradiated PATIENT CHARACTERISTICS: Age: Under 70 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.46 mg/dL Transaminases less than 2 times upper limit of normal Renal: Creatinine no greater than 1.70 mg/dL Creatinine clearance greater than 60 mL/min Other: No prior or concurrent malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin Not pregnant or nursing Negative pregnancy test 24 hours prior to commencing temozolomide PRIOR CONCURRENT THERAPY: No other investigational drugs allowed during this study Biologic therapy: Prior biologic therapy allowed No concurrent biologic therapy allowed No concurrent growth factor to induce neutrophil increase No concurrent erythropoietin Chemotherapy: No prior chemotherapy for metastatic disease At least 3 months since any neoadjuvant and adjuvant treatment, and induction chemotherapy preceding radical radiotherapy Endocrine therapy: See Protocol Outline Concurrent steroids should be maintained on the lowest dose possible Radiotherapy: Prior radiotherapy allowed Concurrent local radiotherapy to nonbrain lesions allowed Concurrent palliative radiation therapy of bone lesions permitted No concurrent radiation to target lesions No concurrent brain radiotherapy Surgery: Prior surgery allowed | |
| 52 | NCT00003118 | completed | 0 | phase 3 | ['esophageal cancer'] | ["['K22.2', 'K22.81', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10']"] | ['cisplatin', 'fluorouracil'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | 1. Patients with histologically documented untreated squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastro-esophageal junction and with less than 2 cm distal spread into the gastric cardia were eligible. 2. No evidence of distant metastatic disease by history and physical examination 3. Upper endoscopy with biopsy, computed tomography (CT) of the chest and upper abdomen, and pulmonary function studies are required. 4. Bone scan is required for alkaline phosphatase more than 3X the institutional normal value. 5. Bronchoscopy is required if the primary tumor was adjacent to the trachea or left main stem bronchus. 6. Patients are required to have: - granulocyte counts ≥1,800/mL - platelet count ≥ 100,000/mL - creatinine clearance ≥ 50 mL/min 7. Esophageal ultrasound (EUS) and preresection staging by thoracoscopy (ts) and laparoscopy/minilaparotomy (ls), including biopsy of celiac axis and lesser curvature are recommended 8. Tumors must be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases. 9. Patients with supraclavicular lymph nodes measuring ≤ 1.5 cm by CT (not palpable) are eligible. 10. Patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) ≤1.5 cm by CT. 11. Patients may not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. 12. Patients with previous malignancies are eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence. 13. There can be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent. Patients with uncontrolled or severe cardio- vascular disease,pulmonary disease, oractive infections are excluded. 14. Pregnant patients are excluded. 15. Informed consent is required for all patients. | |
| 53 | NCT00003120 | completed | 0 | phase 3 | ['fallopian tube cancer', 'ovarian cancer', 'peritoneal cavity cancer'] | ["['C57.00', 'C57.01', 'C57.02']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['paclitaxel'] | ['[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer Must have undergone an initial exploratory laparotomy with tumor debulking AND Must be FIGO stage IIIA, IIIB, IIIC, or IV at the time of initial laparotomy Must have attained a clinically defined complete remission (CR) following treatment with platinum (cisplatin or carboplatin) and paclitaxel based combination chemotherapy regimen by achieving the following: No evidence of cancer on physical examination CA-125 no greater than 35 units/mL Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Bilirubin no greater than 2.0 mg/dL Negative ascites No evidence of residual cancer on CT scan of the abdomen/pelvis or chest x-ray (or chest CT scan, if performed) No symptoms felt to be secondary to persistent malignancy Must have received a minimum of 5 and a maximum of 6 courses of chemotherapy prior to study Must register for study within 21 to 56 days after prior chemotherapy Not concurrently registered to SWOG-S9618, SWOG-S9619, SWOG-S9912, or SWOG-S0009 or front line treatment phase III GOG trials PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: See Disease Characteristics Renal: See Disease Characteristics Other: No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent antitumor treatment No concurrent immunotherapy Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Prior cisplatin allowed if initial dose at least 50 mg/m2 Prior carboplatin allowed if initial dose at least 300 mg/m2 or AUC at least 4 No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy No prior abdominal/pelvic irradiation Surgery: See Disease Characteristics No second look laparotomy or laparoscopy | |
| 54 | NCT00003140 | completed | 1 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['letrozole'] | ['N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis - No ductal carcinoma in situ - Axillary lymph node negative, positive, or unknown - No evidence of metastases - No localized or distant breast cancer recurrence - Not registered on protocol NCCTG-893052, any other IBCSG protocol, or protocol SWOG-S9623 - Hormone receptor status: - Estrogen or progesterone receptor positive as defined by tumor receptor content at least 10 fmol/mg protein or receptor positive by ERICA or PgRICA - Unknown status allowed if effort to determine status has been made by immunocytochemistry - No contralateral breast cancer PATIENT CHARACTERISTICS: Age: - Postmenopausal Sex: - Female Menopausal status: - Postmenopausal defined by one of the following: - Age 50 or over at start of adjuvant tamoxifen - Under age 50 and considered postmenopausal by treating physician at start of adjuvant tamoxifen - Under age 50 at start of adjuvant tamoxifen and had bilateral oophorectomy (surgical or radiation) - Under age 50 and premenopausal at start of adjuvant tamoxifen, but became amenorrheic during tamoxifen and remained amenorrheic for at least 1 year - Considered postmenopausal by physician with LH/FSH levels under the treatment center's postmenopausal limits Performance status: - ECOG 0-2 Life expectancy: - At least 5 years Hematopoietic: - WBC ≥ 3,000/mm^3 OR - Granulocyte count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic: - AST and/or ALT < 2 times upper limit of normal (ULN) (unless imaging examinations have ruled out metastatic disease) - Alkaline phosphatase < 2 times ULN (unless imaging examinations have ruled out metastatic disease) Renal: - Not specified Other: - No concurrent medical or psychiatric condition that would preclude study participation - No other malignancy within the past 5 years except adequately treated superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - Able to swallow study drug - Adequate oral intake PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior adjuvant chemotherapy allowed - No concurrent chemotherapy Endocrine therapy: - Completed at least 4.5 but no more than 6 years of adjuvant tamoxifen after resection - Completed at least 4.5-6 years of adjuvant aromatase inhibitor as initial therapy or after tamoxifen - No more than 3 months since prior adjuvant tamoxifen - No concurrent hormone replacement therapy (e.g., megestrol) - No concurrent selective estrogen-receptor modulators (e.g., raloxifene or idoxifene) - Concurrent intermittent vaginal estrogens (e.g., Estring) allowed if other local measures for intractable vaginal atrophy are insufficient - No other concurrent aromatase inhibitors - No more than 2 years since prior aromatase inhibitor therapy (re-randomization) Radiotherapy: - Prior radiotherapy allowed Surgery: - See Disease Characteristics Other: - At least 1 month since prior investigational drugs - Prior treatment on a clinical trial for breast cancer allowed if permission has been obtained from the sponsors of the original study for their patient to participate on MA.17/JMA.17/BIG-97-01 - No prior placebo on core protocol - No concurrent anticancer therapy - Concurrent thyroid medication, calcium, vitamin D, and bisphosphonates allowed | |
| 55 | NCT00003152 | terminated | low accrual | 0 | phase 3 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cyclophosphamide', 'prednisone', 'vincristine sulfate'] | ['ClCCN(CCCl)P1(=O)NCCCO1', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: Previously untreated follicular stage III or IV non-Hodgkin's lymphoma At least one measurable mass PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Alkaline phosphatase and bilirubin less than 2.5 times upper limit of normal (ULN) (unless clearly related to NHL) Renal: Creatinine and BUN less than 2.5 times ULN (unless clearly related to NHL) Cardiovascular: No severe cardiac disease (e.g. severe heart failure requiring treatment or cardiac ejection fraction less than 45%) Neurologic: No neurologic disease Pulmonary: No pulmonary disease Other: Not pregnant No prior malignancies except nonmelanoma skin cancer or carcinoma in situ of the cervix Not HIV positive No psychiatric or metabolic disease PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent immunotherapeutic drugs, chemotherapy, or radiotherapy |
| 56 | NCT00003172 | completed | 0 | phase 2 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['docetaxel', 'doxorubicin hydrochloride', 'fluorouracil', 'hydroxyurea'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'NC(=O)NO'] | DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction beyond the scope of surgical resection Must have measurable disease in either one or two dimensions either radiographically or by physical examination Measurable disease must be documented outside of a prior radiation portal Evaluable disease only not allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No chronic or unstable angina No uncontrolled congestive heart failure No arrhythmia No chronic angina No myocardial infarction in the past 1 year If history of atherosclerotic heart disease, prior cardiac catheterization or thallium stress test must not suggest coronary artery disease Neurology: No symptomatic peripheral neuropathy greater than grade 2 No cerebellar disease No seizure disorder No organic mental syndrome No major psychoaffective disorder Pulmonary: No chronic obstructive pulmonary disease No chronic bronchitis, emphysema, sarcoid, or bronchiectasis Other: No poorly controlled diabetes mellitus No psychiatric illness No active infections, including AIDS, ARC, or HIV positive No history of hypersensitivity to products containing Polysorbate 80 No history of uncontrolled alcohol or drug abuse No uncontrolled hypercalcemia No other prior malignancy within the past 5 years other than nonmelanomatous skin cancer or cervical carcinoma in situ Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy Endocrine therapy: No chronic use of steroids No concurrent hormonal therapy (except birth control pills) Radiotherapy: At least 1 month since prior radiotherapy No concurrent palliative radiotherapy (arm I patients) Surgery: Must have fully recovered from surgery Other: At least 4 weeks since other investigational agents and recovered from all toxic effects No chronic use of aspirin, nonsteroidal antiinflammatory agents, antianginal medications, or extraordinary antihypertensive regimens | |
| 57 | NCT00003194 | terminated | study enrollment did not meet expected goals | 0 | phase 1 | ['unspecified childhood solid tumor, protocol specific'] | ["['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['carboplatin', 'cyclophosphamide', 'etoposide', 'thiotepa', 'topotecan hydrochloride'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1', 'CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O'] | DISEASE CHARACTERISTICS: - Histologically proven recurrent or refractory pediatric solid tumor - Bone marrow metastases allowed PATIENT CHARACTERISTICS: Age: - 1 to 30 Performance status: - 0-2 Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm3 - Platelet count at least 100,000/mm3 (transfusion independent) - Hemoglobin at least 10 g/dL (RBC transfusion allowed) Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT no greater than 2.5 times normal Renal: - Adequate renal function as defined by one of the following: - GFR by creatinine clearance - Radioisotope GFR - Iothalamate at least 70 mL/min Cardiovascular: - Adequate cardiac function as defined by one of the following: - Ejection fraction at least 55% by MUGA - Fractional shortening at least 28% by echocardiogram Neurologic: - Adequate CNS function as defined by: - Seizure disorder, if present, controlled by anticonvulsants - CNS toxicity no greater than grade 2 Other: - No uncontrolled infections - Not pregnant or nursing - No allergy to platinum compounds - No history of allergy to etoposide (unless mobilization phase not required) PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior immunotherapy - At least 1 week since prior cytokines - At least 3 months since prior bone marrow or peripheral blood stem cell transplantation - No concurrent immunomodulator - No concurrent cytokines Chemotherapy: - At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered - No prior thiotepa - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Recovered from prior radiotherapy - At least 6 months since prior total body irradiation conditioning - No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow Surgery: - Not specified |
| 58 | NCT00003204 | completed | 1 | phase 3 | ['stage iii grade 1 follicular lymphoma', 'stage iii grade 2 follicular lymphoma', 'stage iii grade 3 follicular lymphoma', 'stage iii small lymphocytic lymphoma', 'stage iv grade 1 follicular lymphoma', 'stage iv grade 2 follicular lymphoma', 'stage iv grade 3 follicular lymphoma', 'stage iv small lymphocytic lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cyclophosphamide', 'fludarabine phosphate', 'vincristine sulfate', 'prednisone'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C'] | Inclusion Criteria: - Patients must have Stage III-IV (Ann Arbor classification) low-grade Non-Hodgkin's lymphoma - Baseline measurements and evaluations must be obtained within 4 weeks prior to registration; all areas of disease (evaluable and measurable) should be recorded and mapped out in order to assess response and uniformity of response to therapy; must have at least one objective MEASURABLE disease parameter - Radiographic findings are acceptable providing that clear-cut measurement can be made - Abnormalities on scans may be used to document the presence of disease for staging purposes; a clearly defined, bidimensionally measurable defect or mass measuring at least 2 cm in diameter on a radionuclide or a CT scan will be acceptable as measurable disease - An enlarged spleen extending at least 2 cm below the costal margin will constitute measurable disease providing that no explanation other than lymphomatous involvement is likely; for an enlarged liver to constitute the only evident measurable disease parameter, liver biopsy proof of lymphoma in the liver is required - Patients must have a tissue diagnosis of low-grade malignant lymphoma obtained within 12 months prior to registration (according to the International Working Formulation) as below: - ML- small lymphocytic (Category A) - ML-follicular-small cleaved (Category B) - ML-follicular-mixed small cleaved and large cell (Category C) - Patients having both diffuse and follicular architectural elements will be considered eligible if the histology is predominantly follicular (i.e. >= 50% of the cross-sectional area); if the interval since tissue diagnosis of low-grade malignant lymphoma is > 12 months, diagnostic confirmation using either FNA or nodal biopsy is required to confirm that the histology remains in one of the eligible categories - Women of child bearing potential and sexually active males are strongly advised to use an accepted and effective method of birth control - No prior chemotherapy, radiotherapy, or immunotherapy - No active, uncontrolled infections (afebrile for > 48 hours off antibiotics) - No evidence of a previous or concurrent malignancy, with the exception of 1) treated carcinoma in situ of the cervix, 2) treated squamous cell or basal cell skin cancer OR 3) any other surgically cured malignancy from which the patient has been disease free for at least 5 years - ECOG performance status 0-1 - WBC > 3000/mm^3 - Plts > 100,000/mm^3 - Creatinine =< 1.5 mg/dl - Bilirubin < 2.0 mg/dl - LFTs =< 5x ULN (SGOT and Alkaline Phosphate) - These lab values must be obtained within 4 weeks prior to protocol entry; patients with documented marrow involvement at the time of registration are not required to meet the hematologic parameters above - Patient must give signed informed consent | |
| 59 | NCT00003212 | completed | 0 | phase 3 | ['sarcoma'] | ["['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['doxorubicin hydrochloride', 'ifosfamide'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: Histologically proven advanced or metastatic soft tissue sarcoma including the following: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including haemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Mixed mesodermal tumor of the uterus Measurable disease with evidence of progression in prior 6 weeks No symptomatic or known CNS metastases PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Neutrophil count greater than 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater 1.75 mg/dL Albumin at least 25 g/L Renal: Creatinine clearance greater than 70 mL/min Cardiovascular: No history of uncontrolled cardiovascular disease Other: Fertile women must use effective contraception No other severe medical illness including psychosis No prior primary malignant tumor except: Adequately treated carcinoma in situ of the cervix Basal cell carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No radiotherapy to the sole index lesion Surgery: Not specified | |
| 60 | NCT00003215 | completed | 0 | phase 3 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['chop regimen', 'cyclophosphamide', 'cytarabine', 'doxorubicin hydrochloride', 'etoposide', 'leucovorin calcium', 'melphalan', 'methotrexate', 'methylprednisolone', 'mitoxantrone hydrochloride', 'prednisone', 'therapeutic hydrocortisone', 'vincristine sulfate'] | ['CCO', 'ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1', 'N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C', 'OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', '[H][C@@]12CC[C@](O)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: - Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) - Diffuse large B-cell lymphoma - Primary mediastinal large B-cell lymphoma - Anaplastic large cell lymphoma (B-cell, T-cell, or null-cell type) - At least two of the following risk factors: - Stage III or IV - LDH greater than upper limit of normal (ULN) - ECOG 2, 3, or 4 - No CNS involvement PATIENT CHARACTERISTICS: Age: - 18 to 60 Performance status: - See Disease Characteristics - ECOG 0-4 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No hepatitis B or C - AST or ALT no greater than 2 times ULN* - Bilirubin no greater than 2.34 mg/dL* NOTE: *Unless due to tumor involvement Renal: - Creatinine clearance at least 60 mL/min (unless due to tumor involvement) Cardiovascular: - No significant heart failure - LVEF normal - No active angina pectoris - No myocardial infarction within the past 6 months - No major ventricular arrhythmia Pulmonary: - No significant lung disorder Other: - HIV negative - No severe active acute or chronic infection - No severe psychoses - No prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for NHL (except emergency therapy, but no more than 1 course of standard chemotherapy) Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for NHL (except emergency therapy of no greater than 600 cGy radiation) - No concurrent prophylactic radiotherapy to the brain Surgery: - Not specified | |
| 61 | NCT00003216 | completed | 0 | phase 3 | ['pancreatic cancer'] | ["['C25.3']"] | ['fluorouracil', 'gemcitabine hydrochloride'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F'] | DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the pancreas - Stage T1-4, N0-1 (stage I-IVA) - No M1 or NX staging - Primary tumor of the pancreas (pancreatic head, neck, uncinate process, or body/tail) and maximum diameter/dimension and tumor status at surgical margin known - Prior potentially curative gross resection within 3-8 weeks before study - No non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct carcinoma, or ampullary carcinoma - No recurrent disease - Post-resection CA-19-9 level required PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT no greater than 5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Other: - No significant nausea or vomiting - No prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix - Able to maintain adequate nutrition (at least 1,500 calories/day) - Feeding tube allowed - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics | |
| 62 | NCT00003219 | completed | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['perillyl alcohol'] | ['CC1=NC(C)=C(OC[C@]2(C[C@H]2C(=O)NC2=CC=C(F)C=N2)C2=CC=CC(F)=C2)C=N1'] | DISEASE CHARACTERISTICS: Microscopically confirmed metastatic breast cancer Must be refractory or have recurred after at least 1 systemic chemotherapy regimen Estrogen receptor positive tumors must have failed or recurred after hormonal therapy At least 1 site of measurable disease required Previously radiated lesions are not considered measurable unless there is evidence of disease progression after completion of radiation therapy No known brain metastases Hormone receptor status: Unspecified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 4000/mm3 Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL BUN no greater than 30 mg/dL Other: Effective birth control must be used by fertile patients (barrier method preferred) Not pregnant or nursing PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior treatment Biologic therapy: No immunologic therapy within the past 2 weeks Chemotherapy: No chemotherapy within the past 4 weeks (6 weeks for mitomycin or nitrosoureas) See Disease Characteristics Endocrine therapy: No hormonal therapy within the past 2 weeks See Disease Characteristics Radiotherapy: No radiotherapy within the past 4 weeks See Disease Characteristics Surgery: Not specified Other: No concurrent cholesterol lowering agents, supplemental vitamins, or other antioxidants | |
| 63 | NCT00003223 | terminated | closed due to poor accrual. | 0 | phase 2 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['fenretinide'] | ['C\\C(\\C=C\\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(=O)NC1=CC=C(O)C=C1'] | DISEASE CHARACTERISTICS: Histologically proven oral mucosal intraepithelial neoplasia Stage II: moderate dysplasia, keratosis with atypia Stage III: severe keratinizing or nonkeratinizing dysplasia No myelodysplastic syndrome No retinopathies PATIENT CHARACTERISTICS: See General Eligibility Criteria PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent endocrine therapy Radiotherapy: No concurrent radiotherapy Surgery: Prior surgical ablation of prior dysplastic sites allowed Other: At least 2 months since prior therapy toxicities Patient Characteristics-- Age: Not specified Performance Status: SWOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 1 month before, during, and at least 2 months after study |
| 64 | NCT00003235 | completed | 0 | phase 3 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['carboplatin', 'paclitaxel'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage IIIA or IIIB non-small cell carcinoma of the lung Adenocarcinoma Squamous cell carcinoma Anaplastic large cell carcinoma Stage IIIA patients must not be candidates for resection after neoadjuvant therapy (unresectable T3N1 or T1-3 primary tumors with metastasis limited to the ipsilateral mediastinal and subcarinal lymph nodes) Mediastinotomy or thoracoscopy required for potentially resectable IIIa disease when ipsilateral mediastinal lymph nodes are less than 2 cm Stage IIIB patients must not have significant pleural effusion (seen on CT scan only OR does not reaccumulate after one thoracentesis and is cytologically negative) Metastases to contralateral mediastinal or supraclavicular nodes allowed Measurable or evaluable disease No distant metastasis or significant pleural effusion PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than 2 times normal No liver disease with significant hepatic insufficiency Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac arrhythmia or end stage congestive heart failure Neurologic: No preexisting clinically significant peripheral neuropathy No organic brain syndrome Other: No history of prior or concurrent malignancy in the past 5 years except: Surgically cured basal cell carcinoma of the skin Carcinoma in situ of the cervix Not pregnant Fertile patients must use effective contraception during and for 2 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy Surgery: Not specified | |
| 65 | NCT00003251 | unknown status | 0 | phase 1/phase 2 | ['drug/agent toxicity by tissue/organ', 'head and neck cancer', 'radiation toxicity'] | ["['T86.91', 'T86.92', 'T86.93', 'Z52.9', 'Z94.89', 'Z94.9', 'T86.90']", "['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']", "['K62.7', 'G62.82', 'N46.024', 'N46.124', 'T66.XXXS', 'Z57.1', 'N52.35']"] | ['amifostine trihydrate', 'cisplatin', 'paclitaxel'] | ['NCCCNCCSP(O)(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck Unresectable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 2.5 times normal SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: No other significant infection No other medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months since prior radiotherapy (patients with recurrent disease) to head and neck region Surgery: Not speciified Other: At least 24 hours since antihypertensive medication | |
| 66 | NCT00003256 | completed | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['alvocidib'] | ['CN1CC[C@@H]([C@H](O)C1)C1=C(O)C=C(O)C2=C1OC(=CC2=O)C1=CC=CC=C1Cl'] | PATIENT CHARACTERISTICS: - Performance Status: ECOG 0-2 - Life Expectancy: At least 3 months - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,200/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 8 g/dL - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 2.5 times normal - Creatinine no greater than 1.5 mg/dL - Prostate-specific antigen at least 10 ng/mL (if bone only disease) - No prior or concurrent maligancies within 5 years, except nonmelanoma skin cancer - No serious medical illness - No cord compression symptoms PRIOR CONCURRENT THERAPY: - No prior chemotherapy - No prior suramin therapy - Prior or concurrent use of luteinizing hormone-releasing hormone allowed (no other concurrent hormonal therapy) - No prior anti-androgen therapy within 4 weeks of study - At least 4 weeks since prior radiotherapy - No prior strontium therapy | |
| 67 | NCT00003276 | completed | 0 | phase 2 | ['gallbladder cancer'] | ["['C23', 'D37.6']"] | ['irinotecan hydrochloride'] | ['CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12'] | DISEASE CHARACTERISTICS: Histologically or cytologically proven gallbladder or bile duct carcinoma with metastatic or recurrent disease deemed unresectable and not considered a candidate for potentially curative therapy Measurable or evaluable disease No known active CNS disease Closed to bile duct carcinoma as of July 1999 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 5 times upper limit of normal (ULN) Bilirubin no greater than 1.5 mg/dL OR Bilirubin no greater than 2 times ULN in patients with biliary stents or percutaneous biliary catheters Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: Nutritional intake at least 1200 kcal/day No uncontrolled infection or chronic debilitating disease Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled seizure disorder No prior malignancy within 5 years except adequately treated basal cell/squamous cell carcinomas and adequately treated noninvasive carcinomas PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biological therapy or immunotherapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy: No prior chemotherapy for recurrent or metastatic disease Prior adjuvant chemotherapy allowed if used as a radiation sensitizer for completely resected disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for recurrent or metastatic disease Prior adjuvant radiotherapy allowed if used as a radiation sensitizer for completely resected disease No radiotherapy to greater than 25% of bone marrow No radiotherapy within the past 4 weeks No concurrent radiotherapy Concurrent CNS radiation allowed Surgery: No post abdominal exploration (with or without resection) within the past 4 weeks Other: No concurrent medication for other medical conditions except for: Analgesics Chronic treatments for preexisting conditions Agents required for life-threatening medical conditions No laxatives | |
| 68 | NCT00003292 | terminated | lack of accrual | 0 | phase 2 | ['chondrosarcoma', 'adult fibrosarcoma', 'adult leiomyosarcoma', 'adult rhabdomyosarcoma', 'adult malignant meningioma', 'adult brain malignant hemangiopericytoma'] | ["['R18.0', 'C17.3', 'G21.0', 'J91.0', 'C05.2', 'C10.0', 'C16.0']", "['R18.0', 'C17.3', 'G21.0', 'J91.0', 'C05.2', 'C10.0', 'C16.0']"] | ['ifosfamide'] | ['N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: - Histologically proven recurrent or unresectable: - Malignant meningioma - Intracranial hemangiopericytoma - Primary central nervous system sarcoma, including: - Fibrosarcoma - Rhabdomyosarcoma - Chondrosarcoma - Leiomyosarcoma - Measurable or evaluable disease on CT or MRI scan - Persistent disease following biopsy or incomplete resection OR - Recurrent disease following complete resection - No benign meningioma - No prior or current systemic sarcoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No myocardial infarction within the past 3 months - No active angina - No unstable heart rhythms - No congestive heart failure Other: - HIV negative - No allergy to study drugs - No serious concurrent medical or psychiatric illness - No uncontrolled peptic ulcer disease - No prior malignancy within past 5 years except adequately treated: - Basal or squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Not pregnant or nursing - Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: - Recovered from toxic effects of prior therapy and/or from postoperative complications Biologic therapy: - Not specified Chemotherapy: - No prior ifosfamide - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy (except estrogen replacement therapy) - Corticosteroids allowed if dose is stable or decreasing Radiotherapy: - At least 4 weeks since prior radiotherapy - Progressive disease following radiation required - No concurrent radiotherapy Surgery: - See Disease Characteristics |
| 69 | NCT00003298 | completed | 0 | phase 2 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['cisplatin', 'fluorouracil', 'leucovorin calcium', 'paclitaxel'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | Inclusion Criteria: - Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction - Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0) - No metastatic cancer to the ovaries - Age: 18 and over - Easter Cooperative Oncology Group (ECOG) performance status 0-2 - White blood cell (WBC) count at least 4,000 cells/mm3 - Platelet count at least 150,000/mm3 - Bilirubin less than 2 mg/dL - Creatinine no greater than 1.5 mg/dL - Creatinine clearance greater than 50 mL/min - Caloric intake must be at least 1500 kcal/day - No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix - No prior radiation therapy, except for skin cancer - Fertile patients must use adequate contraception - Met criteria for re-registration after surgery - T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration. - No evidence of metastatic disease from postoperative pathologic staging. - ECOG performance status of 0, 1, or 2 at re-registration - Curative resection performed - Re-registered 4 - 6 weeks from the date of surgery - WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration Exclusion Criteria: - Prior chemotherapy - Clinically significant auditory impairment - Significant heart disease - Pregnant or lactating | |
| 70 | NCT00003317 | completed | 0 | phase 3 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['carboplatin', 'paclitaxel'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically confirmed stage IIIA non-small cell lung cancer that has been completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video assisted resection is acceptable) No known residual disease present Involvement in N2 nodes must have been determined only at the time of surgical exploration or by postoperative pathologic diagnosis All grossly involved nodes must be removed at surgery No positive mediastinoscopy (if lymph nodes on CT scan are greater than 1.5 cm in diameter, mediastinoscopy is required) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ZUBROD 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors Chemotherapy: No prior chemotherapy for non-small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except: Steroids for adrenal failure Hormones for nondisease related conditions Dexamethasone as an antiemetic Radiation therapy: No prior radiotherapy for non-small cell lung cancer Surgery: See Disease Characteristics | |
| 71 | NCT00003376 | completed | 0 | phase 3 | ['bladder cancer', 'transitional cell cancer of the renal pelvis and ureter', 'urethral cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['carboplatin', 'cisplatin', 'doxorubicin hydrochloride', 'methotrexate', 'paclitaxel', 'vinblastine'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the urothelium (renal pelvis, ureter, bladder, or urethra) or mixed histologies containing a component of transitional cell carcinoma of the urothelium with manifestations of progressing regional or metastatic cancer Clinically unsuspected organ-confined prostate cancer found during cystoprostatectomy allowed Evaluable or measurable disease No significant pericardial or pleural effusion or edema No significant ascites No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 2 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No history of severe cardiovascular disease (American Heart Association class III or IV), uncontrolled congestive heart failure, or cardiac dysrhythmias Other: Prior malignancy allowed if curatively treated with no evidence of recurrence No active infection requiring parenteral antibiotics Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy No concurrent filgrastim (G-CSF) within 24 hours prior to and after study chemotherapy administration Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy as a component of bladder-sparing therapy or as an adjuvant for locally advanced disease with positive margins No concurrent local radiotherapy for pain control or life-threatening situations Surgery: See Disease Characteristics | |
| 72 | NCT00003382 | terminated | 0 | phase 1 | ['fallopian tube cancer', 'ovarian cancer', 'primary peritoneal cavity cancer'] | ["['C57.00', 'C57.01', 'C57.02']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['gemcitabine hydrochloride', 'topotecan hydrochloride'] | ['NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F', 'CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O'] | DISEASE CHARACTERISTICS: - Histologically documented refractory or recurrent ovarian epithelial or fallopian tube cancer - No borderline ovarian cancer - Extra-ovarian papillary serous tumors eligible - Must not be eligible for any higher priority phase II or III GOG protocol PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - SGOT no greater than 3 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 mg/dL - Elevated levels of alkaline phosphatase allowed Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No angina pectoris or clinically significant multifocal uncontrolled cardiac dysrhythmias - No uncontrolled hypertension Other: - No other active malignancy - No prior malignancy within the past 5 years except nonmelanomatous skin cancer - No active infection - No underlying medical problem that would prevent compliance - No known hypersensitivity to E. coli-derived drug preparations - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Must have received at least 1 prior platinum- and paclitaxel-based regimen - At least 4 weeks since prior chemotherapy - No prior topotecan and/or gemcitabine - No prior chemotherapy for a different prior malignancy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to more than 10% of bone marrow - At least 2 weeks since limited field radiation therapy Surgery: - Not specified | |
| 73 | NCT00003389 | completed | 0 | phase 3 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['doxorubicin', 'bleomycin', 'vinblastine', 'dacarbazine', 'vincristine', 'mechlorethamine', 'etoposide', 'prednisone', 'cyclophosphamide'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'C[C@@H](O)[C@H](NC(=O)[C@@H](C)[C@H](O)[C@@H](C)NC(=O)[C@@H](NC(=O)C1=C(C)C(N)=NC(=N1)[C@H](CC(N)=O)NC[C@H](N)C(N)=O)[C@@H](OC1OC(CO)C(O)C(O)C1OC1OC(CO)C(O)C(OC(N)=O)C1O)C1=CN=CN1)C(=O)NCCC1=NC(=CS1)C1=NC(=CS1)C(=O)NCCC[S+](C)C', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'N1C=CN=C1', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1', 'CN(CCCl)CCCl', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion criteria: - Histologically proven previously untreated classical Hodgkin's lymphoma - The following stages are eligible: - Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy - Advanced: Stage III or IV - Measurable or evaluable disease - Age of 16 and over - ECOG Performance status 0-2 - Disease-free of prior invasive malignancies for >5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix - White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement) - Platelet count at least 100,000/mm³ (unless documented bone marrow involvement) - Bilirubin no greater than 5.0 mg/dL - Creatinine no greater than 2.0 mg/dL - Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease - Fertile patients must use effective contraception - Prior corticosteroids allowed - Prior surgery allowed Exclusion criteria: - Pregnant or nursing - Prior radiotherapy - Prior chemotherapy - Human immunodeficiency virus (HIV) positive | |
| 74 | NCT00003487 | terminated | withdrawn due to slow enrollment | 0 | phase 2 | ['esophageal cancer'] | ["['K22.2', 'K22.81', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10']"] | ['antineoplaston a10', 'antineoplaston as2-1'] | ['O=C(CC1=CC=CC=C1)N[C@H]1CCC(=O)NC1=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the esophagus that is unlikely to respond to existing therapy and for which no curative therapy exists - Meets 1 of the following criteria: - Metastatic disease - Not curable with surgery or radiotherapy - Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - No hepatic failure - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/ml - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No chronic or congestive heart failure - No uncontrolled hypertension - No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as severe chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No medical illness, psychiatric illness, or non-malignant systemic disease that would preclude study treatment - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: - Concurrent steroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy (except in patients with multiple tumors who have received radiotherapy to some of their tumors) and recovered Surgery: - Recovered from prior surgery Other: - No prior antineoplaston therapy - Prior cytodifferentiating agents allowed |
| 75 | NCT00003567 | terminated | slow accrual | 0 | phase 1 | ['brain and central nervous system tumors', 'lymphoma', 'unspecified adult solid tumor, protocol specific'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['o6-benzylguanine', 'carmustine', 'temozolomide'] | ['N=C1NC2=C(N=CN2)C(OCC2=CC=CC=C2)=N1', 'ClCCNC(=O)N(CCCl)N=O', 'CSCC[C@H](N)C(O)=O'] | DISEASE CHARACTERISTICS: - One of the following histologically confirmed diseases for which no curative surgical, radiotherapy, or chemotherapy programs are available and standard therapy offers, at best, a modest clinical benefit - Solid tumors - Gliomas - Non-Hodgkin's lymphoma - Primary and metastatic CNS malignancies are eligible - Evaluable or measurable disease - CD34 count at least 2.0 cells/μL - No bone marrow involvement - Histologically negative bone marrow biopsy PATIENT CHARACTERISTICS: Age: - 18 to 70 Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST and ALT less than 2.5 times normal - Prothrombin time less than 1.2 times normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No acute cardiac disease by EKG Pulmonary: - No symptomatic pulmonary disease Other: - HIV negative - No other severe comorbid conditions - Not pregnant or nursing - Fertile patients must use effective contraception during and for 2 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: - See Chemotherapy - No prior hematopoietic stem cell transplantation Chemotherapy: - No prior high-dose chemotherapy - Prior adjuvant chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to 25% or more of bone marrow Surgery: - Not specified Other: - At least 4 weeks since prior myelosuppressive therapy |
| 76 | NCT00003592 | completed | 0 | phase 3 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['methotrexate', 'paclitaxel'] | ['CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Histologically confirmed advanced, incurable, squamous cell carcinoma of the head and neck Recurrent disease in a previously irradiated field must be biopsy proven or documented unequivocally by physical exam or radiograph(s) Measurable or evaluable disease Patients with ECOG performance status of 0-1 must be ineligible for protocol E-1395 and unable to tolerate cisplatin-based therapy for 1 or more of the following reasons: Hearing loss that precludes cisplatin Unable to handle a fluid load necessitated by cisplatin-based treatment, due to underlying cardiac or pulmonary disease Mild renal insufficiency (creatinine 1.6-2.0 mg/dL) or creatinine clearance of 40-60 mL/min that would make cisplatin treatment difficult, if not dangerous History of brain metastases allowed if disease has stabilized or improved after radiation and/or craniotomy No history of carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 (See Disease Characteristics) Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: See Disease Characteristics Creatinine no greater than 2.0 mg/dL No evidence of symptomatic hypercalcemia Cardiovascular: See Disease Characteristics No active angina or uncontrolled arrhythmias Metabolic: No uncontrolled diabetes; no random blood sugar at least 300 mg/dL Neurological: No evidence of ongoing grade 2 or greater peripheral sensory neuropathy Pulmonary: See Disease Characteristics Other: No other concurrent, active, invasive malignancies No significant detectable infection Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except in the adjuvant, neoadjuvant, or radiosensitizing setting No prior chemotherapy for recurrent or persistent disease after definitive local therapy At least 6 months since prior methotrexate or paclitaxel Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery | |
| 77 | NCT00003605 | withdrawn | no patient accrual | 0 | phase 2 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cyclophosphamide'] | ['ClCCN(CCCl)P1(=O)NCCCO1'] | DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV indolent B-cell lymphoma Diffuse small cleaved cell lymphoma Follicular small cleaved cell lymphoma Follicular mixed cell lymphoma Follicular large cell lymphoma At least 1 lymph node or visceral lesion at least 2 cm in diameter PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: No active infection No concurrent life threatening disease Not pregnant Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma |
| 78 | NCT00003617 | unknown status | 0 | phase 3 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['chlorambucil', 'clarithromycin', 'omeprazole', 'tinidazole'] | ['OC(=O)CCCC1=CC=C(C=C1)N(CCCl)CCCl', '[H][C@]1(NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](CCN)NC(=O)[C@H](CCNC1=O)NC(=O)[C@H](CCN)NC(=O)[C@@H](NC(=O)[C@H](CCN)NC(=O)CCCCC(C)CC)[C@@H](C)O)[C@@H](C)O', '[Na+].OC([O-])=O', 'CCS(=O)(=O)CCN1C(C)=NC=C1[N+]([O-])=O'] | DISEASE CHARACTERISTICS: Endoscopically diagnosed, unresected, partially resected, or completely resected low grade (stage I) gastric lymphoma Prior diagnosis of H. pylori infection No nodal metastases Microbiological evidence of current H. pylori infection required No pathological evidence of enlarged abdominal lymph nodes by CT scan Gastroscopic ultrasound evidence of enlarged nodes allowed, if CT scan normal PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics | |
| 79 | NCT00003624 | terminated | 0 | phase 2 | ['cervical cancer', 'endometrial cancer', 'fallopian tube cancer', 'neurotoxicity', 'ovarian cancer', 'primary peritoneal cavity cancer', 'sarcoma'] | ["['M50.20', 'M50.21', 'M50.30', 'M50.31', 'M50.80', 'M50.81', 'M50.90']", "['N85.00', 'N85.01', 'N85.02', 'N99.85']", "['C57.00', 'C57.01', 'C57.02']", "['G92.00', 'G92.01', 'G92.02', 'G92.03', 'G92.04', 'G92.05']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']", "['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['amifostine trihydrate', 'cisplatin', 'paclitaxel'] | ['NCCCNCCSP(O)(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: Ovarian, primary peritoneal, cervical, or fallopian tube carcinoma, uterine sarcoma, or endometrial adenocarcinoma for which the proposed treatment is cisplatin plus paclitaxel Must be ineligible for a higher priority GOG protocol PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No hypertension for which medication cannot be discontinued for 24 hours through the day of each chemotherapy treatment Other: No history of neuropathy (e.g., diabetic neuropathy) No significant infection Prior malignancy allowed if disease free for at least 12 months No physical disabilities precluding vibration perception threshold testing of the upper and lower extremity (e.g., amputation, paraplegia) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for ovarian, primary peritoneal, or fallopian tube carcinoma, uterine sarcoma, or endometrial adenocarcinoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy except for cervical carcinoma Surgery: Not specified | |
| 80 | NCT00003625 | completed | 0 | phase 1 | ['brain tumors', 'central nervous system tumors'] | ["['C71.7', 'C71.9', 'C79.31', 'D33.0', 'D33.1', 'D33.2', 'D49.6']", "['C72.9', 'D33.9', 'D43.9', 'D33.7', 'D43.8']"] | ['cyclosporine', 'etoposide', 'vincristine sulfate'] | ['CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI Biopsy is neither necessary nor encouraged A least two-thirds of the tumor is in the pons Origin of the tumor is clearly in the pons Must be registered within 28 days of diagnosis Clinical history less than 6 months duration (cranial nerve deficit, long tract signs, or ataxia) No diffuse leptomeningeal disease PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hepatic: SGPT less than 2 times normal Renal: Creatinine normal for age OR Creatinine clearance greater than 70 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior steroids at stable or decreasing doses allowed Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents | |
| 81 | NCT00003636 | completed | 1 | phase 3 | ['fallopian tube cancer', 'ovarian cancer', 'primary peritoneal cavity cancer'] | ["['C57.00', 'C57.01', 'C57.02']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['carboplatin', 'cisplatin'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | DISEASE CHARACTERISTICS: - Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma - If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true: - Presence of pelvic ovarian mass - Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis - CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor) - Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25) - Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan - No brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: - Creatinine less than 1.25 times ULN Other: - No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy - No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin - No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy | |
| 82 | NCT00003640 | terminated | low accrual | 0 | phase 2 | ['bladder cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['cisplatin', 'doxorubicin hydrochloride', 'methotrexate', 'vinblastine sulfate'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: Transitional cell carcinoma of the bladder with biopsy proven muscle invasion suitable for resection leaving no residual visible or palpable tumor mass Unifocal No greater than 5 cm Stages II and III (T2-T3a, N0-NX, M0) No prior treatment for bladder cancer other than endoscopic resection, intravesical chemotherapy, or intravesical immunotherapy PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT normal Renal: GFR at least 50 mL/min Cardiovascular: Normal cardiac function (i.e., no New York Heart Association class II-IV) Other: Normal auditory function No second primary malignant tumor except basal cell carcinoma of the skin Fit for cisplatin containing combination chemotherapy, radical radiotherapy, or cystectomy No active infections Not pregnant or nursing No concurrent illness that significantly affects clinical assessments PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the bladder Surgery: See Disease Characteristics No prior partial cystectomy Prior transurethral resection of the bladder allowed |
| 83 | NCT00003642 | terminated | low accrual | 0 | phase 2 | ['bladder cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['cisplatin', 'fluorouracil'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | DISEASE CHARACTERISTICS: Histologically confirmed unifocal or multifocal transitional cell carcinoma of the bladder no greater than 5 cm, with evidence of muscle invasion documented by transurethral resection of the bladder (TURB), with no residual visible or palpable tumor mass at the end of TURB Stage II or III (T2-T3, N0, M0) No squamous cell or adenocarcinoma No evidence of pelvic lymph node involvement by CT scan or MRI No evidence of hydronephrosis No evidence of distant metastases No disease in the prostatic urethra PATIENT CHARACTERISTICS: Age: Under 76 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: See Disease Characteristics Creatinine clearance greater than 50 mL/min Cardiovascular: No progressive ischemic cardiopathy Other: No reduced bladder capacity No prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix treated by hysterectomy PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy for superficial disease allowed No concurrent growth factors Chemotherapy: No prior systemic chemotherapy Prior intravesical chemotherapy or intravesical BCG allowed Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: No prior surgery for bladder cancer except transurethral resection of the bladder |
| 84 | NCT00003643 | unknown status | 0 | phase 2/phase 3 | ['extragonadal germ cell tumor', 'teratoma', 'testicular germ cell tumor'] | ["['E29.0', 'E29.1', 'E29.8', 'E29.9', 'E89.5', 'N50.811', 'N50.812']"] | ['cisplatin', 'etoposide', 'paclitaxel'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Histologically proven germ cell cancer - Seminoma - Non-seminoma - Combined - Intermediate prognosis - Non-seminoma: - Testis/retroperitoneal primary - No non-pulmonary visceral metastases - Meets 1 of the following criteria: - Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L - Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L - Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN) - Seminoma: - Any primary site - Any LDH and HCG - AFP normal - Non-pulmonary visceral metastases present PATIENT CHARACTERISTICS: Age: - 16 to 50 Sex: - Male Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times ULN - AST no greater than 2 times ULN Renal: - Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy) Other: - No pre-existing neuropathy - No other malignancy except basal cell skin cancer - No other serious illness or medical conditions incompatible with the protocol PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified | |
| 85 | NCT00003644 | completed | 0 | phase 3 | ['ovarian cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['carboplatin', 'paclitaxel'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC'] | DISEASE CHARACTERISTICS: - Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types: - Serous adenocarcinoma - Malignant Brenner's tumor - Mucinous adenocarcinoma - Endometrioid - Adenocarcinoma - Clear cell adenocarcinoma - Undifferentiated carcinoma - Transitional cell - Mixed epithelial carcinoma - Adenocarcinoma - not otherwise specified - Meets 1 of the following criteria: - Stage Ia or Ib, grade 3 or clear cell - Stage Ic or II, all grades/histologies - Complete surgical staging - No tumors of low malignant potential (borderline tumors) PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-3 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times normal - Alkaline phosphatase no greater than 3 times normal - SGOT no greater than 3 times normal Renal: - Creatinine no greater than 2.0 mg/dL Other: - No other invasive malignancies within the past 5 years except nonmelanoma skin cancer - No major systemic medical illness expected to affect survival - Body surface area no greater than 2.0 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - No prior treatment for this malignancy except surgical staging - No prior anticancer therapy that would preclude study participation | |
| 86 | NCT00003647 | completed | 0 | phase 3 | ['stage iv melanoma', 'stage iii melanoma', 'recurrent melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']", "['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']", "['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']"] | ['allovectin-7', 'allovectin-7/dacarbazine', 'dacarbazine'] | ['CN(C)\\N=N\\C1=C(N=CN1)C(N)=O', 'N1C=CN=C1'] | PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option - Dacarbazine is indicated as first line chemotherapy - At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2 - No history of brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy - Chemotherapy: See Disease Characteristics; No prior chemotherapy - Endocrine therapy: No concurrent immunosuppressive drugs - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: At least 2 weeks since prior major surgery - Other: No other concurrent anticancer drug therapy or experimental therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 80-100% - Life expectancy: At least 24 weeks - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease - Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders | |
| 87 | NCT00003652 | completed | 0 | phase 3 | ['anal cancer'] | ["['C21.1', 'C44.500', 'C44.590', 'D12.9', 'C21.8']"] | ['cisplatin', 'fluorouracil'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | DISEASE CHARACTERISTICS: - Histologically proven nonmetastatic anal cancer - Anal/rectal junction OR - Anal/cutaneous junction with the majority of the tumor in the anal canal, above the junction - Epidermoid cancer (well-differentiated, fairly differentiated, or basaloid) OR - Cloacogenic cancer - Stage II or III - T2 at least 4 cm OR - T3 OR - T4, N0-3, M0 OR - T1, N1-3 OR - T2 (less than 4 cm), N1-3 - Tumors at least 4 cm in greatest dimension and/or tumors with lymph node invasion must be nonmetastatic by ultrasound - No prior surgery to remove tumor PATIENT CHARACTERISTICS: Age: - 80 and under Performance status: - WHO 0 or 1 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 11 g/dL (transfusion allowed) Hepatic: - Not specified Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No cardiac condition contraindicating use of fluorouracil Other: - No prior malignancy within 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or breast - No other serious medical or psychological condition - No serious immunosuppression PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - No prior endocrine therapy Radiotherapy: - No prior pelvic or inguinal radiotherapy Surgery: - See Disease Characteristics - No prior definitive colostomy | |
| 88 | NCT00003653 | completed | 1 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['bicalutamide', 'buserelin', 'cyproterone acetate', 'flutamide', 'goserelin', 'leuprolide acetate', 'nilutamide'] | ['[H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O', '[H][C@@]12C[C@]1([H])[C@@]1(C)C(=CC2=O)C(Cl)=C[C@@]2([H])[C@]3([H])CC[C@](OC(C)=O)(C(C)=O)[C@@]3(C)CC[C@]12[H]', 'CC(C)C(=O)NC1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F', 'CC(C)C[C@H](NC(=O)[C@@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=C1C=CC=C2)NC(=O)[C@H](CC1=CNC=N1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O', 'CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O', 'CC1(C)NC(=O)N(C1=O)C1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F'] | DISEASE CHARACTERISTICS: - Histologically or cytologically proven adenocarcinoma of the prostate prior to the initiation of radiotherapy - Prior pelvic radiotherapy for prostate cancer, either post-radical prostatectomy or as primary management - More than 30 months since prior brachytherapy with curative intent - Prostate-specific antigen must be rising and greater than 3 ng/mL and higher than the lowest level recorded previously since the end of radiotherapy (i.e., higher than the post-radiotherapy nadir) - Total testosterone greater than 5 nmol/L - No definite evidence of metastatic disease - Chest x-ray and bone scan negative for metastases - Radiological changes compatible with nonmalignant diseases allowed - Clinical evidence of local disease allowed PATIENT CHARACTERISTICS: Age: - 16 and over (18 and over for participating centers in the United Kingdom) Performance status: - ECOG 0-1 Life expectancy: - More than 5 years Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 1.5 times ULN - LDH no greater than 1.5 times ULN - No chronic liver disease Renal: - Creatinine no greater than 1.5 times ULN Other: - Sufficiently fluent and willing to complete the quality of life questionnaire in either English or French - Fertile patients must use effective contraception - No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior or concurrent biologic therapy Chemotherapy: - No prior or concurrent chemotherapy Endocrine therapy: - Prior hormonal therapy administered prior to, during, or immediately after radical radiotherapy or prostatectomy allowed provided duration was no longer than 12 months - At least 12 months since prior hormonal therapy Radiotherapy: - See Disease Characteristics - At least 12 months since prior radiotherapy - No concurrent palliative radiotherapy Surgery: - See Disease Characteristics - See Endocrine therapy Other: - No concurrent bisphosphonates | |
| 89 | NCT00003663 | withdrawn | no patient accrual | 0 | phase 2 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['dexamethasone'] | ['C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F'] | DISEASE CHARACTERISTICS: Histologically proven stage III or IV, recurrent or refractory, indolent B cell non-Hodgkin's lymphoma of the following types: Working Group Formulation A (small cell lymphocytic) Working Group Formulation B, C, and D (follicular) Must have relapsed after prior chemotherapy At least 1 lymph node or visceral lesion at least 2 cm in diameter PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No active infection HIV negative No hepatitis B or C No concurrent life threatening condition PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy for lymphoma (e.g., rituximab) Chemotherapy: See Disease Characteristics Endocrine therapy: No other concurrent corticosteroids and/or epinephrine (unless anaphylactic shock) Radiotherapy: Not specified Surgery: Not specified |
| 90 | NCT00003667 | completed | 0 | phase 2 | ['sarcoma'] | ["['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['cyclophosphamide', 'dexrazoxane hydrochloride', 'disaccharide tripeptide glycerol dipalmitoyl', 'doxorubicin hydrochloride', 'vincristine sulfate'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'C[C@@H](CN1CC(=O)NC(=O)C1)N1CC(=O)NC(=O)C1', 'CC1=CC(O)=CC(C)=C1Cl', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: Histologically proven high risk Ewing's family of tumors: Ewing's sarcoma of bone Extraosseous Ewing's sarcoma Peripheral neuroepithelioma Must have one of the following characteristics: Metastatic disease at diagnosis Primary tumor of the humerus, femur, or trunk Bulky (greater than 8 cm) tumor Elevated LDH prior to biopsy (at least 900 IU/mL) PATIENT CHARACTERISTICS: Age: 3 to 60 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Granulocyte count at least 500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 3 times normal Renal: BUN less than 30 mg/dL Creatinine no greater than 1.5 times normal for age OR Creatinine clearance at least 70 mL/min Cardiovascular: Ejection fraction at least 50% OR Fractional shortening at least 29% Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified | |
| 91 | NCT00003679 | unknown status | 0 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['cyclophosphamide', 'docetaxel', 'doxorubicin hydrochloride', 'tamoxifen citrate'] | ['ClCCN(CCCl)P1(=O)NCCCO1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC'] | DISEASE CHARACTERISTICS: Histologically proven previously untreated locally advanced or inflammatory breast cancer Potentially operable disease Tumor at least 3 cm in diameter No metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 60 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: PT and aPTT normal Bilirubin normal (except in patients with benign congenital hyperbilirubinemia) AST/ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN No active hepatitis B or C Liver biopsy normal (if positive serology for hepatitis B or C) Renal: Creatinine normal Cardiovascular: Adequate cardiac function No active cardiac disease Other: Not pregnant Fertile patients must use effective contraception No other serious medical or psychiatric disease No prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior therapy for breast cancer | |
| 92 | NCT00003682 | terminated | lack of inclusions | 0 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['doxorubicin hydrochloride', 'methylprednisolone'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C'] | DISEASE CHARACTERISTICS: Histologically proven, symptomatic prostate cancer Appearance or aggravation of clinical symptoms with progression of disease Bone pain OR Urethral compression OR 20% decrease in performance status Metastatic disease Local-regional or distant secondary tumors Documented radiologically or scintigraphically Hormone-refractory as defined by progression while on hormone treatment (simple castration or complete androgen blockage) Progressive disease No urethral or cervical stenosis Increase of greater than 25% prostatic volume on endorectal echography No documentation by PSA increase or imagery only Hormone castration verified by testosterone less than 0.5 ng/mL No history of CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: No specified Hematopoietic: Neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Ventricular ejection fraction at least 50% Other: No contraindication to anthracycline treatment No prior primary cancer except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Arm I: No concurrent chemotherapy Endocrine therapy: At least 1 month since prior hormone therapy, including estramustine, except LHRH agonists, which continue Arm I: No concurrent estramustine Radiotherapy: At least 3 months since prior strontium 89 No concurrent strontium Surgery: See Disease Characteristics |
| 93 | NCT00003686 | terminated | terminated due to poor accrual. | 0 | phase 3 | ['oral complications', 'quality of life'] | ["['E10.638', 'E11.638', 'E13.638', 'E08.638', 'E09.638']"] | ['pilocarpine hydrochloride', 'placebo'] | ['CC[C@H]1[C@@H](CC2=CN=CN2C)COC1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | DISEASE CHARACTERISTICS: Complaint of dry mouth with ALL the following characteristics: At least 1 week in duration Attributed by the treating physician to an opioid Severity rating at least 20 mm on a 100 mm visual analog scale Must be receiving routine (i.e., not just as needed) dosing with one of the following opioids: morphine, hydromorphone, transdermal fentanyl, methadone, or oxycodone Intent to continue opioid therapy at the same or higher dose over the first 2 weeks that the patient is receiving protocol treatment PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-3 Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Calcium less than 29.9 mg/dL Cardiovascular: No symptomatic congestive heart failure or hypotension (systolic blood pressure less than 100 mm Hg) Pulmonary: No obstructive pulmonary disease (asthma, chronic bronchitis, or chronic obstructive pulmonary disease) Other: No known sensitivity to pilocarpine No active oral candidiasis No Sjogren's syndrome No acute iritis or narrow-angle glaucoma Not pregnant or nursing Effective contraception required of all fertile patients Must be fluent and possess sufficient cognitive ability to complete quality of life questionnaires in either English or French without assistance from a caregiver PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to a field encompassing the parotid glands At least 1 week since prior radiotherapy to the chief site of pain No concurrent radiotherapy to chief site of pain for 2 weeks following randomization Surgery: Not specified Other: No concurrent tricyclic antidepressants (amitriptyline, nortriptyline, desipramine, or imipramine) |
| 94 | NCT00003695 | completed | 0 | phase 3 | ['ovarian cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['chemotherapy'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed stage II or III ovarian epithelial cancer Must be planning to receive platinum-based chemotherapy Must be fit for interval debulking surgery Residual macroscopic disease with longest dimension of largest tumor mass greater than 1 cm in diameter documented at primary surgery or postoperatively by imaging PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No concurrent or prior malignancy likely to interfere with protocol treatments or comparison PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics | |
| 95 | NCT00003701 | completed | 0 | phase 3 | ['bladder cancer', 'urethral cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['carboplatin', 'cisplatin', 'doxorubicin hydrochloride', 'methotrexate', 'paclitaxel', 'vinblastine sulfate'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma of the bladder or mixed histologies containing a component of transitional cell carcinoma Must have undergone radical cystectomy and pelvic lymph node dissection within 12 weeks prior to randomization No evidence of distant metastatic disease on pre- or postoperative radiographic scans No positive surgical margins in the cystectomy specimen and no known macroscopic residual disease left at time of cystectomy No bladder sparing surgery May have undergone continent urinary diversion or neobladder procedure but must have recovered completely from the effects of surgery Must have muscle-invasive disease on final pathologic staging and have a primary tumor stage of pT4, any N, M0, or any pT, N+, M0, or pT3b, any N, any M, and following a pelvic lymph node dissection have a pathologic nodal stage of pN0 (only if pT3b or pT4), pN1, or pN2 Clinically unsuspected organ confined prostate cancer found during cystoprostatectomy allowed PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No second degree atrioventricular block or bundle branch block Other: No history of prior malignancy in the past 5 years except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No active infection requiring antibiotics No history of allergic reaction to drugs utilizing the vehicle Cremophor Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Recovered from all prior therapies Biologic therapy: No prior biologic response modifier therapy No filgrastim (G-CSF) 24 hours pre- or post-chemotherapy administration Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy as a component of bladder sparing therapy No prior adjuvant radiotherapy for locally advanced disease with positive margins Surgery: See Disease Characteristics Other: Prior intravesical therapy for superficial bladder cancer allowed and recovered | |
| 96 | NCT00003728 | unknown status | 0 | phase 3 | ['leukemia', 'lymphoma'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['asparaginase', 'cyclophosphamide', 'cytarabine', 'daunorubicin hydrochloride', 'dexamethasone', 'doxorubicin hydrochloride', 'etoposide', 'leucovorin calcium', 'mercaptopurine', 'methotrexate', 'methylprednisolone', 'mitoxantrone hydrochloride', 'prednisolone', 'therapeutic hydrocortisone', 'thioguanine', 'vincristine sulfate', 'vindesine'] | ['N[C@@H](CC(O)=O)C(O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(C)=O)C(O)=C1C2=O', 'C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', 'NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1', 'S=C1N=CNC2=C1NC=N2', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C', 'OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', '[H][C@@]12CC[C@](O)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C', 'NC1=NC(=S)C2=C(N1)N=CN2', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1', '[H][C@@]12N3CC[C@@]11C4=C(C=C(OC)C(=C4)[C@]4(C[C@@H]5C[N@@](C[C@](O)(CC)C5)CCC5=C4NC4=CC=CC=C54)C(=O)OC)N(C)[C@@]1([H])[C@](O)([C@H](O)[C@]2(CC)C=CC3)C(N)=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed acute lymphoblastic leukemia (ALL) of FAB L1 or L2 morphology - Positive SIg allowed OR - Histologically confirmed precursor B or precursor T lymphoblastic non-Hodgkin's lymphoma (NHL) - No diffuse large cell B-cell lymphoma, Burkitt's lymphoma, or high-grade B-cell lymphoma (Burkitt-like) - Very low-risk (VLR) patients meeting 1 of the following criteria: - ALL of B-cell lineage - WBC less than 10,000/mm^3 - Must meet 1 of the following conditions: - DNA index greater than 1.16 and less than 1.50 and chromosome number 51-66 or unknown - DNA index not assessed and chromosome number 51-66 - DNA index greater than 1.16 and less than 1.50 and chromosome number is unknown - Good response to prephase therapy - Absence of t(9;22) or BCR/ABL, t(4;11)/MLL-AF4, or 11q23/MLL rearrangement - No acute undifferentiated leukemia (AUL) - No CNS or gonadal involvement - Precursor B-lymphoblastic NHL stage I or II OR - Average risk (AR) patients: - Must meet 1 of the following criteria: - ALL with good response to prephase therapy who are neither VLR or very high risk (VHR) - VLR ALL with CNS involvement (CSF positive or negative) - Precursor B-lymphoblastic NHL stage III or IV without any VHR feature - Precursor T-lymphoblastic NHL - AR patients substratified in: - AR1: B-cell lineage ALL with WBC less than 100,000/mm^3 - Surreptitious or hemorrhagic CSF becoming negative at D4 of prephase therapy - Precursor B-lymphoblastic NHL stage III or IV - Precursor T-lymphoblastic NHL stage I or II - AR2: B-cell lineage ALL with WBC at least 100,000/mm^3 - T-cell lineage ALL regardless of the WBC - Overt or non-equivocal CNS involvement at D0 or any CSF involvement at D4 - Gonadal involvement - Precursor T-lymphoblastic NHL stage III or IV - Newborn Down syndrome patients with AR2 features are assigned to the AR1 group OR - VHR patients: - Must meet 1 of the following criteria: - ALL patients meeting 1 of the following conditions: - Poor response to prephase therapy (at least 1,000/mm^3 blasts in peripheral blood after completion of prephase therapy) - t(9;22) or BCR/ABL - t(4;11)/MLL-AF4 = 11q23/MLL rearrangement - Near haploidy (no more than 34 chromosomes or DNA index less than 0.7) - Hypodiploid (35-40 chromosomes or DNA index 0.7 to 0.8) - AUL - For B lineage ALL: failure to achieve complete response (CR) after completion of protocol IA - For T lineage ALL: failure to achieve CR or good partial response (GPR) after completion of protocol IA - Minimal-residual disease (greater than 1,000 blasts/100,000 mononuclear bone marrow cells) at evaluation of IA (day 35) - NHL patients who failed to achieve CR or GPR after completion of protocol IA - All VHR patients are eligible for stem cell transplantation except those whose sole VHR criterion is a poor response to prephase therapy and who have none of the following features: - T-cell immunophenotype - Early B ALL (CD10 negative) - WBC at least 100,000/mm^3 - Newborn Down syndrome patients with VHR features are assigned to AR1 group NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: - Under 18 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No prior therapy | |
| 97 | NCT00003729 | terminated | low accrual | 0 | phase 2 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['cytarabine', 'fludarabine phosphate', 'idarubicin'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O', '[H][C@@]12C[C@H](N(C(=O)[C@H](C)N[C@@H](CCC3=CC=CC=C3)C(=O)OCC)[C@@]1([H])CCCC2)C(O)=O'] | DISEASE CHARACTERISTICS: Cytologically diagnosed relapsed or refractory acute lymphocytic leukemia previously treated with front line therapy FAB L1 or L2 Bone marrow relapse either isolated or associated with CNS or testicular relapse Bone marrow blast cells greater than 10% No isolated CNS relapse PATIENT CHARACTERISTICS: Age: Under 18 Performance status: WHO 0-2 Play-performance scale at least 60% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 times normal Renal: Creatinine less than 2.5 times normal Cardiovascular: No symptoms of cardiac failure No decline of ejection fraction by more than 20% of the lower limit of normal Shortening fraction at least 25% Other: No psychological, familial, sociological or geographical condition that would hamper compliance No uncontrolled infection PRIOR CONCURRENT THERAPY: At least 6 months since prior autologous bone marrow transplantation No prior allogeneic bone marrow transplantation No concurrent treatment with other experimental drug |
| 98 | NCT00003771 | completed | 0 | phase 3 | ['breast cancer', 'menopausal symptoms'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['norethindrone acetate'] | ['CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1'] | DISEASE CHARACTERISTICS: - History of stage 0-II breast cancer with no more than 4 involved axillary nodes if nodal status and number of nodes investigated is known - No current evidence of disease - Hormone receptor status: - Positive, negative, or unknown PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Menopausal or perimenopausal Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No active liver disease Renal: - Not specified Cardiovascular: - No prior or concurrent deep vein thrombosis - No hereditary traits for deep vein thrombosis - No prior or concurrent cerebral stroke - No prior or concurrent coronary disease Other: - No prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No porphyria - No other serious disease that would prevent compliance or greatly limit life expectancy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent chemotherapy Endocrine therapy: - Prior hormone replacement therapy (HRT) allowed if stopped no more than 4 weeks after breast cancer diagnosis and at least 3 months prior to study - No prior HRT initiated after breast cancer diagnosis - No concurrent hormonal therapy for breast cancer except tamoxifen or toremifene Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - No prior randomization into trials comparing effects of chemotherapy and bilateral oophorectomy in premenopausal women | |
| 99 | NCT00003778 | completed | 0 | phase 2 | ['ovarian cancer', 'sarcoma'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']"] | ['dolastatin 10'] | ['CC[C@H](C)[C@@H]([C@@H](CC(=O)N1CCC[C@H]1[C@H](OC)[C@@H](C)C(=O)N[C@@H](CC1=CC=CC=C1)C1=NC=CS1)OC)N(C)C(=O)[C@@H](NC(=O)[C@H](C(C)C)N(C)C)C(C)C'] | DISEASE CHARACTERISTICS: - Histologically proven recurrent or metastatic soft tissue sarcoma - No rhabdomyosarcoma, Ewing's sarcoma, chondrosarcoma, osteogenic sarcoma, mesothelioma, or Kaposi's sarcoma Bidimensionally measurable disease other than previously irradiated disease site(s) even if there has been progression within the radiation field - Pulmonary nodule(s) at least 1 x 1 cm No brain metastases PATIENT CHARACTERISTICS: - Age: 18 and over - Performance status: ECOG 0 or 1 - Absolute neutrophil count at least 2,000/mm3 - Platelet count at least 100,000/mm3 - Bilirubin no greater than 1.5 mg/dL - AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present) - Creatinine no greater than 1.5 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study - No uncontrolled infection - No history of prior malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy in complete remission PRIOR CONCURRENT THERAPY: - No more than 1 prior chemotherapy regimen in the adjuvant setting - No prior chemotherapy for metastatic disease - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - At least 4 weeks since prior radiotherapy - Recovered from prior surgery | |
| 100 | NCT00003782 | completed | 0 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['cyclophosphamide', 'docetaxel', 'doxorubicin'] | ['ClCCN(CCCl)P1(=O)NCCCO1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed invasive adenocarcinoma of the breast - Confined to the breast and ipsilateral axilla on clinical exam - Stage I, II, or IIIA (cT1-3, N0-1, M0) - At least one axillary lymph node with evidence of tumor on histologic exam - Sentinel node biopsy allowed if followed by axillary dissection - No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor - No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign - Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR - Prior lumpectomy and axillary dissection - Patients must receive radiotherapy after randomization (not before) AND after chemotherapy - Margins must be clear - No ipsilateral lymph nodes that are fixed to one another or to other structures (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are considered axillary nodes) - No histologically evident invasive tumor or ductal carcinoma in situ - No diffuse tumors by mammography that would not be surgically amenable to lumpectomy - No other dominant mass in the ipsilateral breast remnant unless one of the following is true: - Histologically benign - Surgically removed with clear margins if malignant - No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude - Tethering or dimpling of the skin or nipple inversion allowed - No metastatic disease - Skeletal pain allowed if bone scan negative for metastases - Hormone receptor status: - Estrogen and progesterone status determined PATIENT CHARACTERISTICS: Age: - greater than or equal to 18 years Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - At least 10 years, excluding diagnosis of cancer Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 (may be less, if in the opinion of the investigator, this represents an ethnic or racial variation) - Platelet count at least 100,000/mm^3* NOTE: *If platelet count is above the upper limit of normal (ULN), significant underlying hematologic disorders must be excluded Hepatic: - Bilirubin no greater than ULN - Alkaline phosphatase less than 2.5 times ULN* - SGOT less than 1.5 times ULN* - No nonmalignant systemic hepatic disease that would preclude study participation NOTE: *Alkaline phosphatase and SGOT cannot both be greater than ULN Renal: - Creatinine no greater than normal - No nonmalignant systemic renal disease that would preclude study participation Cardiovascular: - No nonmalignant systemic cardiovascular disease that would preclude study participation - LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram - No active cardiac disease that would preclude use of doxorubicin or docetaxel, including the following: - Any prior myocardial infarction - Angina pectoris requiring anti-anginal medication - History of congestive heart failure - Cardiac arrhythmia requiring medication - Severe conduction abnormality - Valvular disease with documented cardiac function compromise - Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at least LLN - Poorly controlled hypertension (diastolic greater than 100 mm/Hg) - Hypertension well controlled by medication allowed Other: - No grade 2 or greater peripheral neuropathy - No other prior malignancy within the past 5 years except: - Effectively treated squamous cell or basal cell skin cancer - Surgically treated carcinoma in situ of the cervix - Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No nonmalignant systemic disease that would preclude study participation - No diabetes with morning fasting blood glucose of 200 mg/dL or greater - No psychiatric or addictive disorders that would preclude informed consent - No contraindication to corticosteroids that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for breast cancer Chemotherapy: - No prior chemotherapy for breast cancer - No prior anthracyclines or taxanes - No other concurrent investigational chemotherapy Endocrine therapy: - No prior hormonal therapy for breast cancer - No concurrent hormonal birth control methods or other hormonal therapy - No concurrent raloxifene, including for osteoporosis - Concurrent low-dose topical estrogen in the form of conjugated estrogen ring or conjugated estrogen vaginal cream (dose no more than 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week) allowed Radiotherapy: - See Disease Characteristics - No prior radiotherapy for this malignancy Surgery: - See Disease Characteristics - No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy margins) Other: - No prior systemic therapy for this malignancy - No concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium-channel blockers) for cardiac arrhythmia, angina, or congestive heart failure (allowed if administered for other reasons [e.g., hypertension]) - Concurrent bisphosphonates allowed |