Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED BREAST CANCER
6 other identifiers
interventional
27
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 6, 2003
CompletedFirst Posted
Study publicly available on registry
March 7, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedJune 4, 2013
June 1, 2013
4.1 years
March 6, 2003
June 3, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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
Side effects as assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
Up to 4 years
Secondary Outcomes (1)
Correlation of biologic studies with clinical outcomes
Up to 4 years
Study Arms (1)
Treatment (bevacizumab, docetaxel)
EXPERIMENTALPatients 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed breast cancer
- Local-regional recurrences or metastatic disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases)
- Hormone receptor status:
- Not specified
- Female
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 3 months
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- No bleeding diathesis or coagulopathy
- Bilirubin normal
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Shapiro
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2003
First Posted
March 7, 2003
Study Start
July 1, 2002
Primary Completion
August 1, 2006
Last Updated
June 4, 2013
Record last verified: 2013-06