A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies
- Determine the maximum tolerated dose, dose-limiting toxicity, and safety of BMS-247550
when combined with gemcitabine in patients with advanced solid tumors.
- Determine the plasma pharmacokinetics of this regimen in this patient population.
- Assess, preliminarily, any antitumor activity of this regimen in this patient
OUTLINE: This is a dose-escalation study of BMS-247550.
Patients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV
over 3 hours on day 8. The order of chemotherapy drug administration on day 8 is reversed
during the second course only. Treatment repeats every 21 days for 6 courses in the absence
of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 9 patients
total are treated at the MTD.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Primary Purpose: Treatment
Sibyl Anderson, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|