BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00049244|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: capecitabine Drug: ixabepilone||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||September 2002|
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): NCT00049244
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Linnea Chap, MD||Jonsson Comprehensive Cancer Center|