Combination Chemotherapy in Treating Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer. Determine the toxic effects of this regimen in these patients. Determine the antitumor responses in patients treated with this regimen. OUTLINE: This is a dose-escalation study of cisplatin. Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 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: A total of 15-25 patients will be accrued for this study.

Official Title
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A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: cisplatin
* Drug: triapine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: triapine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific