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Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: capecitabine, paclitaxel

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Wilmington, North Carolina, United States