Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00055861
- Phase
- PHASE2
- Status
- Completed
Conditions
- Recurrent Breast Cancer
- Stage IV Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICALGiven IV
- docetaxel — DRUGGiven IV
- laboratory biomarker analysis — OTHERCorrelative studies
Study Details
This phase II trial is to see if combining bevacizumab with docetaxel works in treating women who have locally advanced or metastatic breast cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
Key Dates
- First listed
- Mar 7, 2003
- Start date
- Jul 31, 2002
- Status verified
- Jun 2013
- Primary completion
- Aug 31, 2006
Study Design
- Enrollment
- 27 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (bevacizumab, docetaxel)Patients receive bevacizumab IV over 30-90 minutes on weeks 1 and 3 and docetaxel IV over 60 minutes on weeks 1, 2, and 3. Treatment repeats every 4 weeks for up to 12 courses in the absence of unacceptable toxicity or disease progression.
Primary Outcome Measure
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 4 years ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | - |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | - |
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