Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133224
Recruitment Status : Terminated (Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.)
First Posted : August 23, 2005
Last Update Posted : September 23, 2008
Information provided by:
Cell Genesys

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel and prednisone) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2005
Primary Completion Date : August 2008
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
2 Drug: Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)

Primary Outcome Measures :
  1. Survival [ Time Frame: 0 ]

Secondary Outcome Measures :
  1. Time to disease progression. Time to pain progression. [ Time Frame: 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00133224

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Sponsors and Collaborators
Cell Genesys

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cell Genesys, Inc. Identifier: NCT00133224     History of Changes
Other Study ID Numbers: G-0034
First Posted: August 23, 2005    Key Record Dates
Last Update Posted: September 23, 2008
Last Verified: September 2008

Keywords provided by Cell Genesys:
Advanced Prostate Cancer
Allogeneic cells

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal