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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
G-0034
NCT ID:
NCT00133224
Start Date:
July 2005
Completion Date:
June 2009
Related Keywords:
- Prostate Cancer
- Advanced Prostate Cancer
- HRPC
- Prostate
- Cancer
- Metastatic
- Hormone-refractory
- GVAX
- Chemotherapy
- Taxotere
- Docetaxel
- Prednisone
- Vaccine
- Allogeneic cells
- Prostatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
| Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick, Maryland 21701 |
| Mary Crowley Medical Research Center | Dallas, Texas 75246 |
| San Bernardino Urology Associates | San Bernardino, California 92404 |
| Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
| Providence Portland Medical Center | Portland, Oregon 97213-3635 |
| California Pacific Medical Center | San Francisco, California 94115 |
| Atlanta Va Medical Center | Decatur, Georgia 30033 |
| Sharp Healthcare | San Diego, California 92121 |
| Gabrail Cancer Center | Canton, Ohio 44718 |
| Hematology Oncology Associates of the Treasure Coast | Port St. Lucie, Florida 34952 |
| The West Clinic | Memphis, Tennessee 38120 |
| Center for Oncology Research & Treatment, PA | Dallas, Texas 75230 |
| Presbyterian Hospital Center for Cancer Research | Charlotte, North Carolina 28204 |
| Dallas Oncology Consultants | Dallas, Texas 75201 |
| Alaska Clinical Research Center | Anchorage, Alaska 99508 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Loma Linda University | Loma Linda, California 92354 |
| Billings Clinic | Billings, Montana 59107-7000 |
| Cancer Research & Prevention Center | Soquel, California 95073 |
| Mobley Research Center | Houston, Texas 77024 |
| Desert Hematology Oncology Medical Group | Rancho Mirage, California 92270 |
| Urology San Antonio Research, PA | San Antonio, Texas 78229 |
| NYU Clinical Cancer Center | New York, New York 10016 |
| St. Edward Mercy Medical Center | Fort Smith, Arkansas 72917 |
| Onocology Care Medical Associates | Los Angeles, California 90057 |
| Kaiser Permanente Medical Group Dept. of Oncology Research | San Diego, California 92120 |
| UCSF Mt. Zion Cancer Center | San Francisco, California 94115 |
| Cancer Center and Department of Medicine | Aurora, Colorado 80010 |
| Jupiter Hematology & Oncology Associates | Jupiter, Florida 33458 |
| Peachtree Hematology & Oncology Consultants, PC | Atlanta, Georgia 30309 |
| Emory Winship Cancer Institute | Atlanta, Georgia 30322 |
| Medical & Surgical Specialists | Galesburg, Illinois 61401 |
| General Clinical Research Center University of Michigan | Ann Arbor, Michigan 48109 |
| Hematology & Oncology Consultants P.C. | Omaha, Nebraska 68122 |
| New Mexico Oncology | Albuquerque, New Mexico 87109 |
| North Shore Hematology Oncology Associates P.C. | East Setauket, New York 11733 |
| Kaiser Permanente Oncology/Hematology | Portland, Oregon 97227 |
| Northwest Cancer Center | Houston, Texas 77042 |
| Seattle Cancer Care Alliance, Univ. of Washington | Seattle, Washington 98109 |
