Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
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/II trial to determine the effectiveness of combining capecitabine and paclitaxel in treating patients who have metastatic breast cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer|
|Study Start Date:||May 2000|
|Study Completion Date:||September 2004|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose (MTD) of capecitabine when combined with paclitaxel in patients with metastatic adenocarcinoma of the breast.
- Determine the clinical efficacy of the dose immediately preceding the MTD identified in phase I, in terms of response rate, time to treatment failure, time to disease progression, and overall survival, in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine a well-tolerated drug combination for these patients.
OUTLINE: This is a dose-escalation, multicenter study of capecitabine.
Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 or more of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the dose level immediately preceding the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and 15-46 patients will be accrued for phase II of this study.
|Bern, Switzerland, CH-3010|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Stefan Aebi, MD||University Hospital Inselspital, Berne|