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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00055861
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    Given IV
  • docetaxel — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

First listed
Mar 7, 2003
Start date
Jul 31, 2002
Status verified
Jun 2013
Primary completion
Aug 31, 2006

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 4 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer Center - Anschutz Cancer PavilionAuroraColorado80045-
Ohio State University Medical CenterColumbusOhio43210-

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