Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement
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: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.
Drug: vinorelbine tartrate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement|
- Maximum-tolerated dose (phase I) [ Designated as safety issue: No ]
- Response rate at the end of study treatment (phase II) [ Designated as safety issue: No ]
- Toxicity at the end of study treatment (phase II) [ Designated as safety issue: Yes ]
- Time to treatment failure at end of study treatment (phase II) [ Designated as safety issue: No ]
- Quality of life by Linear Analogue Self-Assessment indicators with 6 assessments until the end of the course 4 (phase II) [ Designated as safety issue: No ]
|Study Start Date:||March 1999|
|Study Completion Date:||September 2005|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
- 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 these patients.
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 courses 2-4.
Patients are followed every 3 months until disease progression or start of any subsequent antitumor treatment.
PROJECTED ACCRUAL: A total of 98-110 patients will be accrued for this study.