Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement
- Determine the maximum tolerated dose of capecitabine and vinorelbine in elderly women
(65 and older) with metastatic breast cancer.
- Evaluate the efficacy and tolerability of this regimen in these patients.
- Assess the time to treatment failure for this regimen as a first line chemotherapy in
OUTLINE: This is a dose-escalation study of capecitabine and vinorelbine. Patients are
stratified according to bone involvement (yes [closed to accrual as of 12/7/04] vs no).
- Phase I: Patients receive oral capecitabine twice daily on days 1-14 and vinorelbine IV
over 6-10 minutes on days 1 and 8. 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 and vinorelbine until the
maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the dose at
which 2 of 6 patients experience dose limiting toxicity.
- Phase II: Patients receive capecitabine and vinorelbine administered as in phase I, at
the dose preceding the MTD.
Quality of life is assessed during phase II on days 1, 8, and 15 of course 1 and on day 1 of
Patients are followed every 3 months until disease progression or start of any subsequent
PROJECTED ACCRUAL: A total of 98-110 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum-tolerated dose (phase I)
Dagmar Hess, MD
Kantonsspital St. Gallen