Phase I Study of BMS-188797 in Combination With Carboplatin in Patients With Advanced Malignancies
- Determine the recommended phase II dose based on the maximum tolerated dose of
BMS-188797 when administered with carboplatin in patients with advanced nonhematologic
- Assess the dose limiting toxicities and safety of this treatment regimen in these
- 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.
Primary Purpose: Treatment
Daniel M. Sullivan, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|