BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00006086|
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : September 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: BMS-188797 Drug: carboplatin||Phase 1|
- 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 (Clinical Trial)|
|Official Title:||Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||February 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|