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Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
This study has been terminated.
( Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation. )
Study NCT00133224   Information provided by Cell Genesys
First Received: August 19, 2005   Last Updated: September 19, 2008   History of Changes

August 19, 2005
September 19, 2008
July 2005
August 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 NCT00133224 on ClinicalTrials.gov Archive Site
Time to disease progression. Time to pain progression. [ Time Frame: 0 ] [ Designated as safety issue: No ]
Time to disease progression. Time to pain progression. [ Designated as safety issue: No ]
 
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
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

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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Prostate Cancer
  • Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
  • Drug: Chemotherapy (docetaxel and prednisone)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
408
June 2009
August 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
  • 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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Poland,   Sweden,   United Kingdom
 
NCT00133224
Cell Genesys, Inc., Cell Genesys, Inc.
G-0034, VITAL-2
Cell Genesys
 
 
Cell Genesys
September 2008

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