[c09aa8]: / clusters / 9knumclustersv2 / clust_2359.txt

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Patients must be CTC positive (defined as CTCs >= )
Symptomatic peripheral neuropathy >= grade by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version
Symptomatic altered hearing > grade by NCI-CTC version (v) criteria
Patients must have recovered from the toxic effects of prior therapy to < grade toxicity per Common Toxicity Criteria (CTC) version (except deep vein thrombosis)
Toxicities from prior therapies, with the exception of peripheral neuropathy attributable to bortezomib, must have recovered to grade =< according to the Common Toxicity Criteria (CTC) . criteria or to the subjects prior baseline
Peripheral neuropathy of National Cancer Institute (NCI)- Common Terminology Criteria (CTC) grade >=
Severe major organ toxicity; renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade or less (per National Cancer Institute [NCI] Common Toxicity Criteria [CTC] version criteria) with the following exceptions:\r\n* Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase should be =< x upper limit of normal (ULN)\r\n* Serum bilirubin =< x ULN and nausea and vomiting should be =< grade \r\n* Patients with myelosuppression are not excluded if absolute neutrophil count (ANC) >= /uL
Patient has peripheral neuropathy of Grade or greater intensity, or painful Grade , as defined by the NCI CTC.
Otherwise, all toxicity at study entry ? Grade by NCI CTC v..
Presence of neuropathy > Grade (National Cancer Institute Common Toxicity Criteria [NCI CTC]; v.)
Presence of neuropathy > Grade (NCI CTC, Version .)
Symptomatic peripheral neuropathy >= grade by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version
Presence of neuropathy > Grade (NCI CTC, Version .)
Otherwise, all acute toxicity at study entry ? Grade by NCI CTC v., or recovered to baseline
At least weeks has elapsed from any prior therapy, and the patient has recovered from side effects to =< grade toxicities per Common Toxicity Criteria (CTC)
Persistent proteinuria of Common Toxicity Criteria (CTC) grade or higher (>= . g/ hours [hrs])
Grade II or greater peripheral vascular disease based on National Cancer Institute (NCI) Common Toxicity Criteria (CTC); e.g. ischemic rest pain, minor tissue loss, and ulceration or gangrene
Patients have CTC >=
Presence of chronic diarrhea (> grade by Common Toxicity Criteria [CTC] criteria), short bowel syndrome, pancreatic insufficiency, or malabsorption
Symptomatic peripheral neuropathy >= grade by National Cancer Institute (NCI) Common Terminology Criteria (NCI-CTC) version
Unresolved toxicity higher than CTCAE grade (NCI-CTC version .) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)
Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version .) grade <=
Dehydration according to NCI-Common Toxicity Criteria (CTC) v . grade >=
CARBOPLATIN AND PACLITAXEL ARMS: patient with neuropathies of Common Toxicity Criteria (CTC) grade or less
Resolution of all chemotherapy related grade III-IV toxicity as per Common Toxicity Criteria (CTC) criteria .
Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria .
Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version .) grade <=
Active clinically serious infections (i.e. patients currently taking antibiotics)( Grade NCI-CTC Version .)
Peripheral neuropathy >/= Grade (NCI-CTC Version .)
Patients with baseline neurologic symptoms at National Cancer Institute (NCI) Common Toxicity Criteria (CTC) level are not eligible
PART II: Utilizing the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version , values for the following laboratory tests should be no more than grade two levels: ANC, hemoglobin, platelet count, total bilirubin, creatinine, transaminase (AST/ALT), PT, PTT, urine uric acid, urine pH, urine oxalate
History of persistent Grade or higher (National Cancer Institute Common Terminology Criteria [NCI-CTC], Version .) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
Current peripheral neuropathy of NCI-CTC, version . Grade or greater
Patients who have not recovered (Common Toxicity Criteria [CTC] =< grade I) from adverse events due to prior treatments
Peripheral neuropathy > grade (NCI-CTC).
Serum creatinine level greater than CTC grade .
Presence of >= grade non-hematologic toxicity common terminology criteria (CTC) version from the previous treatment
INTERVENTION PHASE: While on neurotoxic chemotherapy, has developed NCI-CTC grade CIPN
Patients with a National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) version (v) sensory neuropathy score of
Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged Grade - by per National Cancer Institute Common Toxicity Criteria (NCI-CTC)
Any patient with a history of a severe reaction (Common Toxicity Criteria [CTC] version [v.] grade >= ) to gadolinium or other contrast agents
Resolution of all chemotherapy related grade III-IV toxicity as per Common Toxicity Criteria (CTC) criteria .
Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria .
Any abnormality that would be scored as NCI Common Terminology Criterial (CTC) grade toxicity that is unrelated to HIV, its treatment, or to KICS that would preclude the use of all of the study treatments or the ability to monitor the natural history of KICS untreated