Paclitaxel and Capecitabine in Treating Women 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 II trial to study the effectiveness of paclitaxel and capecitabine in treating women who have metastatic breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma|
|Study Start Date:||July 1998|
|Estimated Study Completion Date:||July 4, 2002|
|Primary Completion Date:||July 4, 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety, response rate, and efficacy of combination therapy with paclitaxel and capecitabine as first or second line therapy in women with metastatic breast cancer.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1 and capecitabine orally twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival status every 3 months upon completion of treatment.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005649
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28412|
|Study Chair:||William J. Gradishar, MD||Robert H. Lurie Cancer Center|