BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic 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 BMS-188797 and carboplatin in treating patients who have advanced nonhematologic cancer.

Detailed Description
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OBJECTIVES: Determine the recommended phase II dose based on the maximum tolerated dose of BMS-188797 when administered with carboplatin in patients with advanced nonhematologic malignancies. Assess the dose limiting toxicities and safety of this treatment regimen in these patients. Determine the plasma pharmacokinetics of this treatment regimen in these patients. Determine any antitumor activity of this treatment regimen in these patients. OUTLINE: This is a dose escalation study of BMS-188797. Patients receive BMS-188797 IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-188797 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities. Patients are followed for 4 weeks, and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study over 12 months.

Official Title
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Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: BMS-188797
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced nonhematologic malignancy that has progressed on standard therapy or for which no curative therapy exists No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times upper limit of normal (ULN) unless due to hepatic metastases Renal: Creatinine no greater than 1.5 times ULN Other: No chronic medical condition requiring treatment with corticosteroids No prior severe hypersensitivity reaction to agents containing Cremophor (polyoxyethylated castor oil) No serious uncontrolled medical disorder, active infection, or psychiatric disorder (e.g., dementia) that would preclude study No preexisting neurotoxicity grade 1 or greater Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 2 prior chemotherapy regimens for metastatic disease No prior platinum or taxane therapy No other concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy (except megestrol for anorexia/cachexia) and recovered At least 7 days since prior corticosteroids No concurrent corticosteroids No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy to 30% or more of bone marrow and recovered No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational drug

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: BMS-188797|nan|
|Drug: carboplatin|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