An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma
18 Years
75 Years
Female
Breast Cancer
Trial Information
An Open-Label Combination Study of Capecitabine and Standard Paclitaxel Therapy as First or Second Line Therapy in Women With Metastatic Breast Carcinoma
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
William J. Gradishar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067869
NCT ID:
NCT00005649
Start Date:
July 1998
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| PPD Development | Wilmington, North Carolina 28412 |
