Clinical trial NCT00089856: GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Metastatic
Hormone-refractory
GVAX
Chemotherapy
Taxotere
Docetaxel
Prednisone
Vaccine
Allogeneic cells
Advanced Prostate Cancer
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2004-08-18
Enrollment: 626
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival
timeFrame: 0
Secondary outcomes:
measure: Bone pain and bone related events
timeFrame: 0
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Central Alabama Oncology, LLC
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Glendale
country: United States
facility: Palo Verde Hematology/Oncology
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Tuscon
country: United States
facility: ACRC/Arizona Clinical Res. Ctr. Inc.
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cancer Research Center
state: Arkansas
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group, Inc.
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Hem Onc. Medical Group
state: California
city: Greenbrae
country: United States
facility: California Cancer Care
state: California
city: La Mesa
country: United States
facility: Center for Urological Research
state: California
city: Montebello
country: United States
facility: Oncology Care Medical Associates
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Soquel
country: United States
facility: Cancer Research & Prevention Center
state: California
city: Vista
country: United States
facility: San Diego Cancer Center
state: California
city: Aurora
country: United States
facility: Univ. of Colorado Health Science Center
state: Colorado
city: Colorado Springs
country: United States
facility: Cancer Center of Colorado Springs
state: Colorado
city: Bristol
country: United States
facility: The Hope Clinic
state: Connecticut
city: New Britain
country: United States
facility: Urology Center of Grove Hill
state: Connecticut
city: Stamford
country: United States
facility: Carl & Dorothy Bennett Cancer Center
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Community Hospital, Inc.
state: Florida
city: Fort Lauderdale
country: United States
facility: Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
state: Florida
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Miami
country: United States
facility: Oncology-Hematology Group of South Florida/Advanced Medical Specialists
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Safety Harbor
country: United States
facility: Urology Consultants
state: Florida
city: Atlanta
country: United States
facility: Atlanta VAMC
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Hematology Oncology Consultants, PC
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care, P.C.
state: Georgia
city: Honolulu
country: United States
facility: Straub Clinic & Hospital
state: Hawaii
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic Research Center
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology/Hematology Inc.
state: Indiana
city: Lafayette
country: United States
facility: Louisiana Oncology Associates
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Frederick
country: United States
facility: Frederick Memorial Hospital Regional Cancer Therapy Center
state: Maryland
city: Free Soil
country: United States
facility: West Michigan Regional Cancer and Blood Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital, Cancer Clinical Trials Office
state: Michigan
city: Southfield
country: United States
facility: Newland Medical Associates, P.C.
state: Michigan
city: St. Louis
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic
state: Montana
city: Billings
country: United States
facility: Hematology/Oncology Centers of the Northern Rockies, P.C.
state: Montana
city: Omaha
country: United States
facility: Omaha VA Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Omaha VA Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Cherry Hill
country: United States
facility: The Center for Cancer & Hematologic Disease
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Associates of Northern New Jersey
state: New Jersey
city: Summit
country: United States
facility: Summit Medical Group/Overlook Oncology Center
state: New Jersey
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital/ Center for Cancer Research
state: North Carolina
city: Hickory
country: United States
facility: Northwestern Carolina Hematology Oncology, PA
state: North Carolina
city: Bismarck
country: United States
facility: Medcenter One Cancer Care / Odyssey Research
state: North Dakota
city: Fargo
country: United States
facility: Dakota Cancer Institute
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation, Taussig Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Bala Cynwyd
country: United States
facility: Urologic Surgery PC
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Cancer Center, Ltd
state: Pennsylvania
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Chattanooga
country: United States
facility: Memorial Health Care System
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Amarillo
country: United States
facility: The Don and Sybil Harrington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment PA
state: Texas
city: Dallas
country: United States
facility: Urology Specialists and Associates, P.A.
state: Texas
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Bennington
country: United States
facility: Southwestern Oncology Research Department
state: Vermont
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center Urology
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Edegem
country: Belgium
facility: University Hospital Antwerp (UZA)
city: Gent
country: Belgium
facility: UZ Gent
city: Gent
country: Belgium
facility: Unversity Hospial Gent
city: Hasselt
country: Belgium
facility: Virga Jesse Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Roeselare
country: Belgium
facility: Heilig Hartziekenhuis Roeselare Men
city: Sint-Truiden
country: Belgium
facility: Regionaal Ziekenhuis Sint Trudo
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHUM Notre-Dam
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Pointe-Claire
country: Canada
facility: Ultra Med Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hopitalier Universitaire de Sherbrooke
state: Quebec
city: Angers Cedex
country: France
facility: Centre Paul Papin
city: Caen Cedex 5
country: France
facility: Centre Francois Baclesse
city: Dijon Cedex
country: France
facility: Centre Georges Francois Leclerc
city: Lyon Cedex
country: France
facility: Centre Leon Berard Service de Cancerologie Medicale
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nantes-Saint Herblain
country: France
facility: Centre Rene Gauducheau
city: Reims Cedex
country: France
facility: Institut Jean Godinot
city: Vandoeuvre les Nancy Cedex
country: France
facility: Centre Alexis Vautrin
city: Aachen
country: Germany
facility: Universitatsklinikum Aachen Urologie
city: Dresden
country: Germany
facility: der Technischen Universitat Dresden
city: Essen
country: Germany
facility: Universitatsklinik um Essen
city: Homburg/Saar
country: Germany
facility: Universitatsklinik um des Saarlande
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Linkoping
country: Sweden
facility: University Hospital, Linkoping
city: Lund
country: Sweden
facility: University Hospital Lund
city: Uppsala
country: Sweden
facility: Akademiska University Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
city: Leeds
country: United Kingdom
facility: St. James's University Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hosptial
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Oxford
country: United Kingdom
facility: Oxford Cancer Centre, Churchill Hospital
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Wales
country: United Kingdom
facility: Glan Clwyd Hospital
Study officials:
References:
citation: 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.