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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Mary-Ellen Taplin, MD
Study ID
NCT00321646
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The main purpose of this trial is to collect information and to evaluate the effects, good or bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate cancer that are undergoing radical prostatectomy.

Key Dates

First listed
May 4, 2006
Start date
Jun 30, 2006
Status verified
Apr 2016
Primary completion
Nov 30, 2008
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: chemotherapy
    docetaxel and bevacizumab prior to prostatectomy

Primary Outcome Measure

Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy [ Time Frame: after 6 months of neoadjuvant chemotherapy. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02114-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MADuke University Medical Center· Durham, NC

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