Official Title
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Phase
Phase 2Lead Sponsor
Oncology Specialties, AlabamaStudy Type
InterventionalStatus
TerminatedIndication/Condition
Metastatic Breast CancerIntervention/Treatment
capecitabine docetaxel ...Study Participants
43In this phase II study, we plan to evaluate the efficacy, safety and tolerability of weekly docetaxel and capecitabine on a 21-day cycle followed by maintenance single agent capecitabine for the treatment of metastatic breast cancer, Based on the efficacy and toxicity of the combination regimen dosages previously reviewed; weekly docetaxel 30mg/m2 on days 1 and 8 plus capecitabine 1600mg/m2 (800mg/m2 orally twice daily)on day 1 through 14 of each cycle will be utilized.
Inclusion Criteria: must have metastatic breast cancer must have cytologically or pathologically confirmed invasive ductal or lobular carcinoma must have measurable or evaluable disease ECOG of 0-1 patients may have received 0, 1. or 2 prior treatments for metastatic breast cancer must have adequate organ function must be at least 19 years of age peripheral neuropathy less than or equal to grade 1 must have voluntarily signed informed consent patients with brain metastases are eligible provided that other measurable disease exists and brain lesions are controlled Exclusion Criteria: patients with other malignancies, except non melanoma of the skin, who have had any evidence of cancer within the last 5 years patients with psychiatric illness or other concurrent severe co-morbid medical condition that would preclude study completion known uncontrolled existing coagulopathy patients with a history of severe hypersensitivity reaction to docetaxel, medications formulated with polysorbate 80 or 5-fluorouracil use of other investigational agents in the last 28 days pregnant or lactating women patients who are known HIV positive patients with life expectancy of less than 3 months sexually active patients unwilling to practice reliable contraception during the study