Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

Tracking Information
First Submitted Date ICMJE	March 6, 2003
First Posted Date ICMJE	March 7, 2003
Last Update Posted Date	June 4, 2013
Study Start Date ICMJE	July 2002
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 12, 2012)	Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 4 years ]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 ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00055861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 12, 2012)	Correlation of biologic studies with clinical outcomes [ Time Frame: Up to 4 years ]; 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.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Official Title ICMJE	PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED BREAST CANCER
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.
Detailed Description	PRIMARY OBJECTIVES: 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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Recurrent Breast Cancer; Stage IV Breast Cancer
Intervention ICMJE	Biological: bevacizumab Given IV Other Names: anti-VEGF humanized monoclonal antibody anti-VEGF monoclonal antibody Avastin rhuMAb VEGF; Drug: docetaxel Given IV Other Names: RP 56976 Taxotere TXT; Other: laboratory biomarker analysis Correlative studies
Study 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.; Interventions: Biological: bevacizumab; Drug: docetaxel; Other: laboratory biomarker analysis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 12, 2012)	27
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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; AST/ALT no greater than 2.5 times upper limit of normal; INR less than 1.5 (patients receiving warfarin); Creatinine normal; Creatinine clearance at least 60 mL/min; No baseline proteinuria Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg; No symptomatic congestive heart failure; No cardiac arrhythmia; No uncontrolled hypertension; No history of stroke; No clinically significant peripheral artery disease; No arterial thromboembolic event within the past 6 months, including any of the following: Transient ischemic attack Cerebrovascular accident Unstable angina Myocardial infarction; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No seizures not controlled with standard medical therapy; No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents; No psychiatric illness or social situation that would preclude study compliance; No ongoing or active infection; No other concurrent uncontrolled illness; No non-healing wounds; No significant traumatic injury within the past 28 days; Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease) More than 6 months since prior taxane-containing adjuvant chemotherapy; More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered; More than 3 weeks since prior radiotherapy; More than 28 days since prior major surgery or open biopsy; More than 7 days since prior fine needle aspirations other than in the breast; More than 7 days since prior placement of a vascular access device; No concurrent major surgical procedure; No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters); No other concurrent investigational agents; No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications (known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00055861
Other Study ID Numbers ICMJE	NCI-2012-01433; OSU 0218; NCI-2715; OSU-0218; UCHSC-01239; CDR0000271359
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Cancer Institute (NCI)
Study Sponsor ICMJE	National Cancer Institute (NCI)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Charles Shapiro Ohio State University
PRS Account	National Cancer Institute (NCI)
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP