Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Stopped early · Phase 2
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00225056
- Run by
- Oncology Specialties, Alabama
- People needed
- 43
- Starts
- 2003-10-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2007-04-20
Who can join
Age: 19 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Comprehensive Cancer Institute — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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