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| Descriptive Information Fields | |
| Brief Title † | GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer |
| Official Title † | A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve |
| Brief Summary | The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past. As this is a survival trial and it is difficult to predict when deaths or the primary/secondary endpoints will occur, the anticipated completion dates provided represent the actual completion of accrual, and the timeframes for the primary/secondary endpoints cannot be accurately estimated. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | Survival [ Time Frame: 0 ] [ Designated as safety issue: No ] |
| Secondary Outcome Measure † | Bone pain and bone related events [ Time Frame: 0 ] [ Designated as safety issue: No ] |
| Condition † | Prostate Cancer |
| Intervention † | Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone) |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Active, not recruiting |
| Enrollment † | 600 |
| Start Date † | July 2004 |
| Completion Date | September 2007 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Male |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States, Belgium, Canada, France, Germany, Netherlands, Sweden, United Kingdom |
| Administrative Information Fields | |
| NCT ID † | NCT00089856 |
| Organization ID | G-0029 |
| Secondary IDs †† | (VITAL-1) |
| Study Sponsor † | Cell Genesys |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Cell Genesys |
| Verification Date | December 2007 |
| First Received Date † | August 16, 2004 |
| Last Updated Date | December 19, 2007 |