3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Unspecified Adult Solid Tumor, Protocol Specific focused on measuring unspecified adult solid tumor, protocol specific
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed progressive advanced or metastatic cancer Failed 1 or more prior standard therapies for disease OR Unlikely to respond to any currently available therapies Measurable or evaluable disease No active CNS metastases Previously treated CNS metastases allowed if no evidence of new CNS metastases and stable for at least 2 months PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) No active bleeding or coagulation disorder (occult blood for gastrointestinal cancer allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL ALT/AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Albumin at least 3.0 g/dL PT/PTT no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active heart disease No myocardial infarction within the past 3 months No symptomatic coronary artery disease, heart block, or uncontrolled congestive heart failure Pulmonary: No moderate to severe compromise in pulmonary function Other: No mental deficits and/or psychiatric history that would preclude study No active infection No pre-existing severe hearing impairment No pre-existing grade 2 or greater neuropathy No prior severe allergic reaction to study drugs No other life-threatening illness No chronic toxic effects from prior chemotherapy greater than grade I Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 18 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent hematopoietic growth factors allowed except if used prophylactically during first course of study therapy Chemotherapy: More than 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered More than 6 months since prior combination cisplatin and paclitaxel Prior cisplatin or paclitaxel as single agents allowed Prior 3-AP allowed Endocrine therapy: Not specified Radiotherapy: More than 3 weeks since prior radiotherapy and recovered Concurrent radiotherapy to a single site of progressive disease allowed if site requires treatment within the first course of study therapy Surgery: Not specified Other: More than 3 weeks since any therapy for malignancy and recovered No other concurrent investigational drugs without consent of sponsor
Sites / Locations
- Albert Einstein Comprehensive Cancer Center
- New York Presbyterian Hospital - Cornell Campus