BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: BMS-188797 Drug: carboplatin||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies|
|Study Start Date:||June 2000|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006086
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Daniel M. Sullivan, MD||H. Lee Moffitt Cancer Center and Research Institute|