Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

November 30, 2008

Study Completion Date

December 31, 2012

Conditions
Prostate CancerAdenocarcinoma of the Prostate
Interventions
DRUG

Bevacizumab

Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center.

DRUG

Docetaxel

Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.

Trial Locations (3)

27710

Duke University Medical Center, Durham

02114

Beth Israel Deaconess Medical Center, Boston

02115

Dana-Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Duke University

OTHER

collaborator

Genentech, Inc.

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

Mary-Ellen Taplin, MD

OTHER