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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
  • Immunotherapy allogeneic GM-CSF secreting cellular vaccine
• Drug: Chemotherapy (docetaxel and prednisone)
  • Chemotherapy (docetaxel and prednisone)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Other: 2

Primary Measures

• Survival
  • Time Frame: 0
    Safety Issue?: No

Secondary Measures

• Time to disease progression. Time to pain progression.
  • Time Frame: 0
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cell Genesys

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00133224

Study ID Number: G-0034

ClinicalTrials.gov Identifier: NCT00133224

Health Authority: United States: Food and Drug Administration