Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
NCT00133224 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408
Last updated 2008-09-23
Summary
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
Conditions
Interventions
- BIOLOGICAL
-
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
- DRUG
-
Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
Sponsors & Collaborators
-
Cell Genesys
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Primary Completion
- 2008-08-31
- Completion
- 2009-06-30
Countries
- United States
- Belgium
- Canada
- France
- Germany
- Italy
- Netherlands
- Poland
- Sweden
- United Kingdom
Study Locations
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