Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Stefan Aebi, MD
University Hospital Inselspital, Berne