{
"info": {
"nct_id": "NCT00001272",
"official_title": "A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE",
"exclusion_criteria": "",
"miscellaneous_criteria": "All patients must have biopsy proven ovarian cancer as determined by evaluation in the Laboratory of Pathology, NCI.\n\nGerm cell and borderline histologies are specifically excluded.\n\nPatients must have FIGO stage III and IV disease, or FIGO Stage IIC disease with poorly differentiated histology, and will undergo attempted surgical debulking prior to the initiation of chemotherapy.\n\nPrior chemotherapy or radiation therapy will make a patient ineligible.\n\nPerformance status: less than or equal to ECOG 2.\n\nPatients must have the following end organ function:\n\nNo brain involvement.\n\nNo history of myocardial infarction, cardiac arrhythmias requiring\n\ntherapy, right bundle branch block with left anterior hemiblock, and left bundle branch block.\n\nRenal function: creatinine clearance greater than or equal to 60 cc/min; patients with ureteral obstruction must have this corrected prior to starting therapy.\n\nHepatic function: normal coagulation parameters, serum transaminases within 3 times upper limit of normal.\n\nNeurologic function: no preexisting dysfunction greater than grade 1 (exclusive of mild vibratory delay).\n\nNo recent history of active GI bleeding.\n\nHematologic parameters prior to starting cycle 1 of therapy: total granulocyte count greater than 2000 and platelet count greater than 100,000.\n\nPatients may not have had prior history of invasive malignancy with the exception of nonmelanoma skin cancer curatively treated.\n\nPatients must be able to give written informed consent and express a willingness to meet all of the expected requirements of the protocol.\n\nPatients must be able to begin therapy within 8 weeks of staging laparotomy and should have a central venous catheter placed for infusion of chemotherapy.\n\nAll patients must be registered by calling the Orkand Corporation at 402-1732 between the hours of 8:30 AM and 5:00 PM; eligibility criteria will be queried."
},
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{
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{
"and_criteria": [
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"and_criteria": [
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"unit": "times upper limit of normal"
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"and_criteria": [
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}