Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED BREAST CANCER|
- Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]The response rate will be estimated with exact binomial 95% confidence intervals.
- Side effects as assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
- Correlation of biologic studies with clinical outcomes [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Associations between laboratory endpoints (pre-study plasma VEGF and IL-8, E-selectin, P-selectin, CD31, ICAM-1, VCAM_1, CD44, PDGF, FGF, MMP-2 and MMP-9.) and response or toxicity will be investigated using Wilcoxon rank-sum tests for ordinal or continuous endpoints, or chi-square tests for binary or categorical endpoints.
|Study Start Date:||July 2002|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
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.
Other Names:Drug: docetaxel
Other Names:Other: laboratory biomarker analysis
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055861
|United States, Colorado|
|University of Colorado Cancer Center - Anschutz Cancer Pavilion|
|Aurora, Colorado, United States, 80045|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Charles Shapiro||Ohio State University|