Overview
Combination Chemotherapy in Treating Patients With Advanced Cancer
Status:
Completed
Completed
Trial end date:
2003-06-01
2003-06-01
Target enrollment:
0
0
Participant gender:
All
All
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 with cisplatin in treating patients who have advanced cancer.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vion PharmaceuticalsTreatments:
Cisplatin
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed progressive malignant disease that has failed at least 1
conventional treatment or is unlikely to respond to current therapy
- Measurable or evaluable disease
- Elevated serum tumor marker considered evaluable disease
- No known active CNS metastases
- Previously treated CNS metastases with no evidence of new CNS metastases allowed
if stable for at least 2 months
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- 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 (except occult blood related to
gastrointestinal cancer)
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT and AST no greater than 3 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 5 times ULN
- PT and 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
- No uncontrolled arrhythmias
- No uncontrolled congestive heart failure
Pulmonary:
- No moderate to severe compromise of pulmonary function
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infectious process
- No pre-existing severe hearing impairment
- No grade 2 or greater neuropathy
- No other life threatening illness
- No prior severe allergic reaction to cisplatin
- No mental deficits and/or psychiatric history that would preclude study
- No persistent chronic toxic effects from prior chemotherapy greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 2 weeks since prior biologic therapy
Chemotherapy:
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered
- At least 3 months since prior cisplatin or platinum analogue
- No prior 3-AP
Endocrine therapy:
- At least 2 weeks since prior hormonal therapy
Radiotherapy:
- More than 3 weeks since prior radiotherapy
Surgery:
- At least 3 weeks since prior major surgery and recovered
Other:
- No other concurrent investigational drugs
- No other concurrent nephrotoxic drugs (e.g., aminoglycoside antibiotics)