Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
• Patients in phase I:
• * Evaluable disease
• Patients in phase II:
• * Bidimensionally measurable disease
• * Bone metastases are not considered measurable
• No known or clinically suspected CNS metastases
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age:
• 18 to 64
• Sex:
• Not specified
• Menopausal status:
• Not specified
• Performance status:
• WHO 0-2
• Life expectancy:
• At least 12 weeks
• Hematopoietic:
• WBC greater than 3,500/mm\^3
• Platelet count greater than 100,000/mm\^3
• Hemoglobin at least 10 g/dL
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 2 times ULN (3 times ULN if liver metastases present)
• Renal:
• Patients in phase I:
• * Creatinine clearance at least 50 mL/min
• Patients in phase I or II:
• * Creatinine no greater than 1.5 times ULN
• Cardiovascular:
• No grade 2 or greater atrioventricular block
• Other:
• No cognitive impairment or severe psychiatric disorder
• No greater than grade 2 preexisting peripheral neuropathy
• No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• Able to tolerate steroid premedication
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• More than 6 months since prior adjuvant chemotherapy
• At least 1 year since prior continuous infusion of fluorouracil or capecitabine
• At least 1 year since prior taxane administered once every 3 weeks
• No prior taxane or capecitabine administered weekly
• No more than 1 prior chemotherapy regimen for metastatic or locally advanced breast cancer
• No other concurrent chemotherapy
• Endocrine therapy:
• Prior hormonal treatment for metastatic breast cancer allowed
• No concurrent continuous glucocorticosteroids
• No concurrent systemic endocrine treatment for breast cancer
• Radiotherapy:
• No concurrent radiotherapy to indicator lesion or more than 30% of bone marrow
• Surgery:
• Not specified
• Other:
• No other concurrent anticancer treatment
• No concurrent immunosuppressive drugs
• Concurrent bisphosphonates allowed if indicator lesion is non-bone
• Able to tolerate steroid premedication