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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

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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
Links
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.




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