Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced Breast Cancer
Phase I/II Trial of Capecitabine With Weekly Paclitaxel for Advanced 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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
Patients in phase I:
Patients in phase II:
Bidimensionally measurable disease
No known or clinically suspected CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Patients in phase I:
Patients in phase I or II:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: