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

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

This study is currently 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 ^†	Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
Official Title ^†	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. 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 estimated 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 ^†	Time to disease progression. Time to pain progression. [ Time Frame: 0 ] [ Designated as safety issue: No ]
Condition ^†	Prostate Cancer
Intervention ^†	Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel and prednisone)
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Recruiting
Enrollment ^†	600
Start Date ^†	July 2005
Completion Date	June 2009
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 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 ^††
Location Countries ^†	United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Sweden, United Kingdom

Administrative Information Fields
NCT ID ^†	NCT00133224
Organization ID	G-0034
Secondary IDs ^††	VITAL-2
Study Sponsor ^†	Cell Genesys
Collaborators ^††
Investigators ^†
Information Provided By	Cell Genesys
Verification Date	June 2008
First Received Date ^†	August 19, 2005
Last Updated Date	June 18, 2008

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