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

NCT00133224 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2008-09-23

No results posted yet for this study

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

BIOLOGICAL

Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Immunotherapy allogeneic GM-CSF secreting cellular vaccine

DRUG

Chemotherapy (docetaxel and prednisone)

Chemotherapy (docetaxel and prednisone)

Sponsors & Collaborators

  • Cell Genesys

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2008-08-31
Completion
2009-06-30

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133224 on ClinicalTrials.gov