Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	August 19, 2005
Last Updated Date	September 19, 2008
Start Date ^ICMJE	July 2005
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 19, 2007)	Survival [ Time Frame: 0 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 13, 2007)	Survival [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00133224 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 19, 2007)	Time to disease progression. Time to pain progression. [ Time Frame: 0 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 13, 2007)	Time to disease progression. Time to pain progression. [ Designated as safety issue: No ]

Descriptive Information
Brief Title ^ICMJE	Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
Official Title ^ICMJE	A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain
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 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel and prednisone)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	408
Estimated Completion Date	June 2009
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Sweden, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00133224
Responsible Party	Cell Genesys, Inc., Cell Genesys, Inc.
Study ID Numbers ^ICMJE	G-0034, VITAL-2
Study Sponsor ^ICMJE	Cell Genesys
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cell Genesys
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP