Prostate Cancer Clinical Trial
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
| Verified date | November 2008 |
| Source | Cell Genesys |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 626 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | ZNA Middelheim | Antwerp | |
| Belgium | Imelda Ziekenhuis | Bonheiden | |
| Belgium | University Hospital Antwerp (UZA) | Edegem | |
| Belgium | Unversity Hospial Gent | Gent | |
| Belgium | UZ Gent | Gent | |
| Belgium | Virga Jesse Ziekenhuis | Hasselt | |
| Belgium | AZ Groeninge | Kortrijk | |
| Belgium | Heilig Hartziekenhuis Roeselare Men | Roeselare | |
| Belgium | Regionaal Ziekenhuis Sint Trudo | Sint-Truiden | |
| Canada | CHUM Notre-Dam | Montreal | Quebec |
| Canada | McGill University | Montreal | Quebec |
| Canada | Ultra Med Inc. | Pointe-Claire | Quebec |
| Canada | Centre Hopitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
| Canada | Princess Margaret Hospital | Toronto | Ontario |
| France | Centre Paul Papin | Angers Cedex | |
| France | Centre Francois Baclesse | Caen Cedex 5 | |
| France | Centre Georges Francois Leclerc | Dijon Cedex | |
| France | Centre Leon Berard Service de Cancerologie Medicale | Lyon Cedex | |
| France | Institut Paoli-Calmettes | Marseille | |
| France | Centre Rene Gauducheau | Nantes-Saint Herblain | |
| France | Institut Jean Godinot | Reims Cedex | |
| France | Centre Alexis Vautrin | Vandoeuvre les Nancy Cedex | |
| Germany | Universitatsklinikum Aachen Urologie | Aachen | |
| Germany | der Technischen Universitat Dresden | Dresden | |
| Germany | Universitatsklinik um Essen | Essen | |
| Germany | Universitatsklinik um des Saarlande | Homburg/Saar | |
| Netherlands | VU Medisch Centrum | Amsterdam | |
| Netherlands | University Medical Centre Groningen | Groningen | |
| Sweden | University Hospital, Linkoping | Linkoping | |
| Sweden | University Hospital Lund | Lund | |
| Sweden | Akademiska University Hospital | Uppsala | |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | Beatson Oncology Centre | Glasgow | |
| United Kingdom | St. James's University Hospital | Leeds | |
| United Kingdom | Hammersmith Hospital | London | |
| United Kingdom | Mount Vernon Hospital | Middlesex | |
| United Kingdom | Newcastle General Hospital | Newcastle upon Tyne | |
| United Kingdom | Northampton General Hosptial | Northampton | |
| United Kingdom | Nottingham City Hospital | Nottingham | |
| United Kingdom | Oxford Cancer Centre, Churchill Hospital | Oxford | |
| United Kingdom | Scunthorpe General Hospital | Scunthorpe | |
| United Kingdom | Royal Hallamshire Hospital | Sheffield | |
| United Kingdom | Glan Clwyd Hospital | Wales | |
| United States | Central Alabama Oncology, LLC | Alabaster | Alabama |
| United States | The Don and Sybil Harrington Cancer Center | Amarillo | Texas |
| United States | Alaska Clinical Research Center | Anchorage | Alaska |
| United States | Atlanta VAMC | Atlanta | Georgia |
| United States | Georgia Cancer Specialists | Atlanta | Georgia |
| United States | Peachtree Hematology Oncology Consultants, PC | Atlanta | Georgia |
| United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
| United States | Univ. of Colorado Health Science Center | Aurora | Colorado |
| United States | Urologic Surgery PC | Bala Cynwyd | Pennsylvania |
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Southwestern Oncology Research Department | Bennington | Vermont |
| United States | Deaconess Billings Clinic | Billings | Montana |
| United States | Hematology/Oncology Centers of the Northern Rockies, P.C. | Billings | Montana |
| United States | Medcenter One Cancer Care / Odyssey Research | Bismarck | North Dakota |
| United States | Boca Raton Community Hospital, Inc. | Boca Raton | Florida |
| United States | The Hope Clinic | Bristol | Connecticut |
| United States | Jacobi Medical Center | Bronx | New York |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Charleston Hematology Oncology | Charleston | South Carolina |
| United States | Presbyterian Hospital/ Center for Cancer Research | Charlotte | North Carolina |
| United States | Memorial Health Care System | Chattanooga | Tennessee |
| United States | The Center for Cancer & Hematologic Disease | Cherry Hill | New Jersey |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| United States | Cleveland Clinic Foundation, Taussig Cancer Center | Cleveland | Ohio |
| United States | Cancer Center of Colorado Springs | Colorado Springs | Colorado |
| United States | Compassionate Cancer Care Medical Group, Inc. | Corona | California |
| United States | Center for Oncology Research and Treatment PA | Dallas | Texas |
| United States | Mary Crowley Medical Research Center | Dallas | Texas |
| United States | Urology Specialists and Associates, P.A. | Dallas | Texas |
| United States | Welborn Clinic Research Center | Evansville | Indiana |
| United States | Dakota Cancer Institute | Fargo | North Dakota |
| United States | Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital | Fort Lauderdale | Florida |
| United States | Fort Wayne Medical Oncology/Hematology Inc. | Fort Wayne | Indiana |
| United States | Pacific Coast Hem Onc. Medical Group | Fountain Valley | California |
| United States | Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland |
| United States | West Michigan Regional Cancer and Blood Center | Free Soil | Michigan |
| United States | Palo Verde Hematology/Oncology | Glendale | Arizona |
| United States | California Cancer Care | Greenbrae | California |
| United States | Northwestern Carolina Hematology Oncology, PA | Hickory | North Carolina |
| United States | Straub Clinic & Hospital | Honolulu | Hawaii |
| United States | Mobley Research Center | Houston | Texas |
| United States | Integrated Community Oncology Network | Jacksonville | Florida |
| United States | Medical Oncology Associates | Kingston | Pennsylvania |
| United States | Center for Urological Research | La Mesa | California |
| United States | Louisiana Oncology Associates | Lafayette | Louisiana |
| United States | Lancaster Cancer Center, Ltd | Lancaster | Pennsylvania |
| United States | Urological Associates of Lancaster | Lancaster | Pennsylvania |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| United States | Arkansas Cancer Research Center | Little Rock | Arkansas |
| United States | Central Georgia Cancer Care, P.C. | Macon | Georgia |
| United States | The West Clinic | Memphis | Tennessee |
| United States | Oncology-Hematology Group of South Florida/Advanced Medical Specialists | Miami | Florida |
| United States | Oncology Care Medical Associates | Montebello | California |
| United States | Hematology-Oncology Associates of Northern New Jersey | Morristown | New Jersey |
| United States | Urology Center of Grove Hill | New Britain | Connecticut |
| United States | Columbia University Medical Center | New York | New York |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Cancer Centers of Florida | Ocoee | Florida |
| United States | University of Oklahoma | Oklahoma City | Oklahoma |
| United States | Omaha VA Medical Center | Omaha | Nebraska |
| United States | Omaha VA Medical Center | Omaha | Nebraska |
| United States | UC Irvine Medical Center | Orange | California |
| United States | University of Pittsburgh Cancer Center | Pittsburgh | Pennsylvania |
| United States | Hematology Oncology Associates of the Treasure Coast | Port St. Lucie | Florida |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | William Beaumont Hospital, Cancer Clinical Trials Office | Royal Oak | Michigan |
| United States | Urology Consultants | Safety Harbor | Florida |
| United States | Urology San Antonio | San Antonio | Texas |
| United States | San Bernardino Urological Associates | San Bernardino | California |
| United States | Sharp Healthcare | San Diego | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Virginia Mason Medical Center Urology | Seattle | Washington |
| United States | Cancer Research & Prevention Center | Soquel | California |
| United States | Newland Medical Associates, P.C. | Southfield | Michigan |
| United States | Hematology Oncology Consultants, Inc. | St. Louis | Missouri |
| United States | Carl & Dorothy Bennett Cancer Center | Stamford | Connecticut |
| United States | Summit Medical Group/Overlook Oncology Center | Summit | New Jersey |
| United States | SUNY Upstate Medical University | Syracuse | New York |
| United States | ACRC/Arizona Clinical Res. Ctr. Inc. | Tuscon | Arizona |
| United States | Tyler Cancer Center | Tyler | Texas |
| United States | San Diego Cancer Center | Vista | California |
| Lead Sponsor | Collaborator |
|---|---|
| Cell Genesys |
United States, Belgium, Canada, France, Germany, Netherlands, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival | 0 | No | |
| Secondary | Bone pain and bone related events | 0 | No |
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