Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining 3-AP, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.
Detailed description
OBJECTIVES: * Determine the safety and tolerability of 3-AP, cisplatin, and paclitaxel in patients with advanced or metastatic cancer. * Determine the toxic effects of this regimen in these patients. * Determine the maximum tolerated dose and recommended phase II dose of this regimen in these patients. * Determine the pharmacokinetic parameters of this regimen in these patients. * Determine the tumor response in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive 3-AP IV continuously over 96 hours on days 1-4 and paclitaxel IV over 3 hours followed by cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy after documented CR. Patients with partial response or stable disease may receive therapy for up to 6 months. Cohorts of 1-6 patients receive escalating doses of 3-AP, paclitaxel, and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Interventions
DRUGcisplatin
DRUGpaclitaxel
DRUGtriapine
Sponsors
Vion Pharmaceuticals
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed