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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00055861
Other study ID # NCI-2012-01433
Secondary ID OSU 0218NCI-2715
Status Completed
Phase Phase 2
First received March 6, 2003
Last updated June 3, 2013
Start date July 2002

Study information

Verified date June 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
bevacizumab
Given IV
Drug:
docetaxel
Given IV
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado
United States Ohio State University Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Side effects as assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 Up to 4 years No
Secondary Correlation of biologic studies with clinical outcomes 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. Up to 4 years No
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