Status:
TERMINATED
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
Lead Sponsor:
Cell Genesys
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 doce...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases
- ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
- Any Gleason score
- Only one prior treatment with systemic chemotherapy
- No prior treatment with gene therapy
- No prior immunotherapy for prostate cancer
- Taxane naïve
- Experiencing cancer-related pain
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00133224
Start Date
July 1 2005
End Date
June 1 2009
Last Update
September 23 2008
Active Locations (115)
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1
Alaska Clinical Research Center
Anchorage, Alaska, United States, 99508
2
St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72917
3
Loma Linda University
Loma Linda, California, United States, 92354
4
Onocology Care Medical Associates
Los Angeles, California, United States, 90057