BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer

H. Lee Moffitt Cancer Center and Research Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

BMS-188797DRUG

carboplatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Data from ClinicalTrials.gov

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