Status:
TERMINATED
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
Lead Sponsor:
Oncology Specialties, Alabama
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
19-85 years
Phase:
PHASE2
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00225056
Start Date
October 1 2003
End Date
November 1 2006
Last Update
April 20 2007
Active Locations (1)
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1
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801