Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00110214
Phase
PHASE3
Status
Completed

Conditions

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer

Eligibility Criteria

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

Interventions

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

Study Details

This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than docetaxel and prednisone in treating prostate cancer.

Key Dates

First listed
May 5, 2005
Start date
Apr 30, 2005
Status verified
Dec 2012
Primary completion
Mar 31, 2010
Completion
Aug 31, 2011

Study Design

Enrollment
1,050 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1. Patients also receive oral prednisone once daily on days 1-21.
  • Experimental: Arm II
    Patients receive docetaxel and prednisone as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1.

Primary Outcome Measure

Overall Survival [ Time Frame: Duration of study (up to 5 years) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
Cancer and Leukemia Group BChicagoIllinois60606-

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By research site
Yale University· New Haven, CTCancer and Leukemia Group B· Chicago, IL

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