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A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve


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

- Any Gleason score

- ECOG performance status 0-2

Exclusion Criteria:

- Prior treatment with chemotherapy

- Prior Immunotherapy

- Prior treatment with gene therapy

- Significant 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-0029

NCT ID:

NCT00089856

Start Date:

July 2004

Completion Date:

October 2008

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Cancer
  • Metastatic
  • Hormone-refractory
  • GVAX
  • Chemotherapy
  • Taxotere
  • Docetaxel
  • Prednisone
  • Vaccine
  • Allogeneic cells
  • Advanced Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
University of Illinois at ChicagoChicago, Illinois  60612
Dakota Cancer InstituteFargo, North Dakota  58103-4940
Virginia Oncology AssociatesNewport News, Virginia  23606
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Georgia Cancer SpecialistsDecatur, Georgia  30033
Louisiana Oncology AssociatesLafayette, Louisiana  70506
University of OklahomaOklahoma City, Oklahoma  73190
Seattle Cancer Care AllianceSeattle, Washington  98109
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
Jacobi Medical CenterBronx, New York  10461
Mary Crowley Medical Research CenterDallas, Texas  75246
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Tyler Cancer CenterTyler, Texas  75702
Memorial Health Care SystemChattanooga, Tennessee  37404
SUNY Upstate Medical UniversitySyracuse, New York  13210
Deaconess Billings ClinicBillings, Montana  59107-5100
Arkansas Cancer Research CenterLittle Rock, Arkansas  72205
Providence Portland Medical CenterPortland, Oregon  97213-3635
California Pacific Medical CenterSan Francisco, California  94115
Center for Urological ResearchLa Mesa, California  91942
Cancer Centers of FloridaOrlando, Florida  32806
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
California Cancer CareGreenbrae, California  94904
Sharp HealthcareSan Diego, California  92121
San Diego Cancer CenterVista, California  92083
Charleston Hematology OncologyCharleston, South Carolina  29403
Gabrail Cancer CenterCanton, Ohio  44718
San Bernardino Urological AssociatesSan Bernardino, California  
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Summit Medical Group/Overlook Oncology CenterSummit, New Jersey  07901
Medical Oncology AssociatesKingston, Pennsylvania  18704
UC Irvine Medical CenterOrange, California  
Hematology Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
The West ClinicMemphis, Tennessee  38120
Atlanta VAMCDecatur, Georgia  30033
West Michigan Regional Cancer and Blood CenterLudington, Michigan  49431
Lancaster Cancer Center, LTDLancaster, Pennsylvania  17605
Alaska Clinical Research CenterAnchorage, Alaska  99508
Cancer Center of Colorado SpringsColorado Springs, Colorado  80907
Columbia University Medical CenterNew York, New York  10032
The Don and Sybil Harrington Cancer CenterAmarillo, Texas  79106
Southwestern Oncology Research DepartmentBennington, Vermont  05201
Straub Clinic & HospitalHonolulu, Hawaii  96813
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Central Alabama Oncology, LLCAlabaster, Alabama  35007
Palo Verde Hematology/OncologyGlendale, Arizona  85304
ACRC/Arizona Clinical Res. Ctr. Inc.Tuscon, Arizona  85715
Pacific Coast Hem Onc. Medical GroupFountain Valley, California  92708
Oncology Care Medical AssociatesMontebello, California  90640
Cancer Research & Prevention CenterSoquel, California  95073
Univ. of Colorado Health Science CenterAurora, Colorado  80045
The Hope ClinicBristol, Connecticut  06010
Urology Center of Grove HillNew Britain, Connecticut  06052-1395
Carl & Dorothy Bennett Cancer CenterStamford, Connecticut  06902
Boca Raton Community Hospital, Inc.Boca Raton, Florida  33486
Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross HospitalFort Lauderdale, Florida  33308
Oncology-Hematology Group of South Florida/Advanced Medical SpecialistsMiami, Florida  33176
Urology ConsultantsSafety Harbor, Florida  34695
Peachtree Hematology Oncology Consultants, PCAtlanta, Georgia  30309
Central Georgia Cancer Care, P.C.Macon, Georgia  31201
Welborn Clinic Research CenterEvansville, Indiana  47713
Fort Wayne Medical Oncology/Hematology Inc.Fort Wayne, Indiana  46815
William Beaumont Hospital, Cancer Clinical Trials OfficeRoyal Oak, Michigan  48073-6706
Newland Medical Associates, P.C.Southfield, Michigan  48075
Hematology Oncology Consultants, Inc.St. Louis, Missouri  63136
Hematology/Oncology Centers of the Northern Rockies, P.C.Billings, Montana  59101
Omaha VA Medical CenterOmaha, Nebraska  68198-7680
The Center for Cancer & Hematologic DiseaseCherry Hill, New Jersey  08003
Hematology-Oncology Associates of Northern New JerseyMorristown, New Jersey  07962
Presbyterian Hospital/ Center for Cancer ResearchCharlotte, North Carolina  28204
Northwestern Carolina Hematology Oncology, PAHickory, North Carolina  28602
Medcenter One Cancer Care / Odyssey ResearchBismarck, North Dakota  58501
Cleveland Clinic Foundation, Taussig Cancer CenterCleveland, Ohio  44195
Urologic Surgery PCBala Cynwyd, Pennsylvania  19004
University of Pittsburgh Cancer CenterPittsburgh, Pennsylvania  15232
Urology Specialists and Associates, P.A.Dallas, Texas  75231
Center for Oncology Research and Treatment PADallas, Texas  75230
Mobley Research CenterHouston, Texas  77024
Urology San AntonioSan Antonio, Texas  78229
Virginia Mason Medical Center UrologySeattle, Washington  98101