GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

Phase 3 Terminated 626 enrolled Cell Genesys

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

Timeline

Start: 2004-07
Primary completion: 2008-10
Completion: 2008-10

Outcome

Outcome not reported

Stopped: “Based on futility analysis showing \<30% chance of meeting primary endpoint.”

Publications

Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	75 mg/m2	—
Subject	GVAX	Cell therapy	3e+08 cells	—
Subject	Prednisone	Other / unclassified	—	—