Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/17/2017 |
| Start Date: | July 1998 |
| End Date: | July 4, 2002 |
An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma
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.
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.
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.
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.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic breast cancer
Bidimensionally measurable disease Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 75 Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: ANC at
least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times
upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Other: Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Eligible patients
may have received prior chemotherapy in metastatic or adjuvant setting with the following
exceptions: At least 12 months since prior fluoropyrimidine therapy At least 12 months
since prior taxane therapy Only 1 previous chemotherapeutic regimen in the metastatic
setting Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy Surgery: Not specified
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