A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline
- Determine the maximum tolerated dose of BMS-247550 and capecitabine, on 2 different
schedules, in patients with metastatic breast cancer previously treated with a taxane
and an anthracycline.
- Determine the safety profile of this regimen in these patients.
- Determine, preliminarily, any antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups.
- Group I: Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine
twice daily on days 1-14.
- Group II: Patients receive BMS-247550 IV over 1 hour on days 1-3 and capecitabine as in
Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease
progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of BMS-247550 and capecitabine until the
maximum tolerated dose (MTD) is determined for each group. The MTD is defined as the dose at
which no more than 1 of 6 patients experiences dose-limiting toxicity. Additional patients
are treated at the MTD.
Patients are followed for at least 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 34-60 patients will be accrued for this study within 8-12
Primary Purpose: Treatment
Linnea Chap, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|