Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00005649|
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : August 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: capecitabine Drug: paclitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||July 4, 2002|
|Study Completion Date :||July 4, 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005649
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28412|
|Study Chair:||William J. Gradishar, MD||Robert H. Lurie Cancer Center|