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

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cell Genesys
• Treatments: Docetaxel; Prednisone; Vaccines

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