Expired Study
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Tampa, Florida 33612


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00006086


Primary Contact:

Study Chair
Daniel M. Sullivan, MD
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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