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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00055861
First received: March 6, 2003
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Recurrent Breast Cancer
Stage IV Breast Cancer
Biological: bevacizumab
Drug: docetaxel
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 27
Study Start Date: July 2002
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055861

Locations
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
Sponsors and Collaborators
Investigators
Principal Investigator: Charles Shapiro Ohio State University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00055861     History of Changes
Other Study ID Numbers: NCI-2012-01433, OSU 0218, NCI-2715, OSU-0218, UCHSC-01239, CDR0000271359
Study First Received: March 6, 2003
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Antibodies, Monoclonal
Docetaxel
Bevacizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014