PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED BREAST CANCER
I. Determine the response rate in women with locally advanced or metastatic breast cancer
treated with bevacizumab and docetaxel.
II. Determine the side effects of this regimen in these patients. III. Correlate soluble
activated endothelial cell markers and adhesion molecules, quantitation of tumor and/or
endothelial cell apoptosis, and quantitation of microvessel density with clinical outcome in
patients treated with this regimen.
OUTLINE: This is a multicenter study. 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.
After completion of 6 courses of combined treatment, patients with an ongoing response may
receive bevacizumab alone in the absence of disease progression.
PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 14-27
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
The response rate will be estimated with exact binomial 95% confidence intervals.
Up to 4 years
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|
|University of Colorado Cancer Center - Anschutz Cancer Pavilion||Aurora, Colorado 80045|