Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00016107
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • estramustine phosphate sodium — DRUG
    Given orally
  • docetaxel — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Key Dates

First listed
Jun 10, 2003
Start date
Jun 30, 2001
Status verified
Jun 2013
Primary completion
Feb 28, 2007

Study Design

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

Arms

  • Experimental: Treatment (chemotherapy, bevacizumab)
    Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour followed by bevacizumab IV over 30-90 minutes on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Time to objective progression [ Time Frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer and Leukemia Group BChicagoIllinois60606-

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By research site
Cancer and Leukemia Group B· Chicago, IL

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