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GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
This study has been terminated.
( Based on futility analysis showing <30% chance of meeting primary endpoint. )
Study NCT00089856   Information provided by Cell Genesys
First Received: August 16, 2004   Last Updated: November 3, 2008   History of Changes

August 16, 2004
November 3, 2008
July 2004
October 2008   (final data collection date for primary outcome measure)
Survival [ Time Frame: 0 ] [ Designated as safety issue: No ]
Survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00089856 on ClinicalTrials.gov Archive Site
Bone pain and bone related events [ Time Frame: 0 ] [ Designated as safety issue: No ]
Bone pain and bone related events [ Designated as safety issue: No ]
 
GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
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

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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Prostate Cancer
  • Biological: Immunotherapy with allogeneic prostate vaccine
  • Drug: Chemotherapy (Taxotere and prednisone)
  • Other: Standard of care - chemotherapy
  • Experimental: Immunotherapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
626
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Germany,   Netherlands,   Sweden,   United Kingdom
 
NCT00089856
Cell Genesys, Inc, Cell Genesys, Inc.
G-0029, (VITAL-1)
Cell Genesys
 
 
Cell Genesys
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP