Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Phase 2
Terminated
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT00225056
- Lead Sponsor
- Oncology Specialties, Alabama
- Brief Summary
In 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 43
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall clinical benefit rate
- Secondary Outcome Measures
Name Time Method safety and tolerability evaluate QOL determine progression free survival determine time to response and overall survival
Trial Locations
- Locations (1)
Comprehensive Cancer Institute
🇺🇸Huntsville, Alabama, United States