GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer - Tabular View

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GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

This study is ongoing, but not recruiting participants.
Information provided by Cell Genesys

This Tabular View shows the required WHO registration data elements as marked by ^†

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
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Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	600
Start Date ^†	July 2004
Completion Date	September 2007
Eligibility Criteria ^†	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 Any Gleason score ECOG performance status 0-2 Exclusion Criteria: Prior treatment with chemotherapy Prior Immunotherapy Prior treatment with gene therapy Significant cancer related pain
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

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.