Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
Stopped early · Phase 3
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00133224
- Run by
- Cell Genesys
- People needed
- 408
- Starts
- 2005-07-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2008-09-23
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- St. Edward Mercy Medical Center — Fort Smith, Arkansas, United States
- Loma Linda University — Loma Linda, California, United States
- Onocology Care Medical Associates — Los Angeles, California, United States
- Desert Hematology Oncology Medical Group — Rancho Mirage, California, United States
- San Bernardino Urology Associates — San Bernardino, California, United States
- Kaiser Permanente Medical Group Dept. of Oncology Research — San Diego, California, United States
- Sharp Healthcare — San Diego, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- UCSF Mt. Zion Cancer Center — San Francisco, California, United States
- Cancer Research & Prevention Center — Soquel, California, United States
- Cancer Center and Department of Medicine — Aurora, Colorado, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Jupiter Hematology & Oncology Associates — Jupiter, Florida, United States
- Lakeland Regional Cancer Center — Lakeland, Florida, United States
- Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
- Atlanta VA Medical Center — Atlanta, Georgia, United States
- Peachtree Hematology & Oncology Consultants, PC — Atlanta, Georgia, United States
- Emory Winship Cancer Institute — Atlanta, Georgia, United States
- Medical & Surgical Specialists — Galesburg, Illinois, United States
- James Graham Brown Cancer Center — Louisville, Kentucky, United States
- Frederick Memorial Hospital Regional Cancer Therapy Center — Frederick, Maryland, United States
- General Clinical Research Center University of Michigan — Ann Arbor, Michigan, United States
- Billings Clinic — Billings, Montana, United States
- Hematology & Oncology Consultants P.C. — Omaha, Nebraska, United States
- Alaska Clinical Research Center — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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