Clinical Trials Directory

Trials / Terminated

TerminatedNCT00133224

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

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
408 (actual)
Sponsor
Cell Genesys · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALImmunotherapy allogeneic GM-CSF secreting cellular vaccineImmunotherapy allogeneic GM-CSF secreting cellular vaccine
DRUGChemotherapy (docetaxel and prednisone)Chemotherapy (docetaxel and prednisone)

Timeline

Start date
2005-07-01
Primary completion
2008-08-01
Completion
2009-06-01
First posted
2005-08-23
Last updated
2008-09-23

Locations

115 sites across 10 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT00133224. Inclusion in this directory is not an endorsement.