Combination Chemotherapy in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: 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 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals
• Treatments: 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)