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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
Not Enrolling
Male
Prostate Cancer

Thank you

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