NCT00049244

BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: R-Pharm · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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 combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.

Detailed description

OBJECTIVES: * 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 group I. 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 months.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	ixabepilone

Timeline

• Start date: 2002-09-01
• First posted: 2003-01-27
• Last updated: 2017-01-30

Locations

1 site across 1 country: United States