Prostate Cancer Clinical Trial
Official title:
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
Verified date | September 2008 |
Source | Cell Genesys |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
Status | Terminated |
Enrollment | 408 |
Est. completion date | June 2009 |
Est. primary completion date | August 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 - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Netwerk Antwerpen - AZ Middelheim | Antwerpen | |
Belgium | V.Z.W. Imelda Ziekenhuis | Bonheiden | |
Belgium | AZ Groeninge | Kortrijk | |
Belgium | CHU de Liège - Hôpital du Sart Tilman | Liège | |
Belgium | Heilig-Hartziekenhuis Campus Wilgenstraat | Roeselare | |
Belgium | Regionaal Ziekenhuis Sint Trudo | Sint Truiden | |
Canada | Centre Hospitalier de L'Universite de Montreal | Montreal | Quebec |
Canada | Centre Hospitalier Universite de Sherbrooke | Sherbrooke | Quebec |
France | Centre Regional de lutte contre le cancer Paul Papin | Angers | |
France | Centre Francois Baclesse | Caen | |
France | Institut Jean Godinot, Oncologie Medicale | Cedex | |
France | Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne | Clermont-Ferrand | |
France | Centre Rene Gauducheau - Site Hospitalier Nord | Nantes | |
France | Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer | Nice | |
France | CHU Saint Louis | Paris | |
France | Hopital Cochin | Paris | |
France | Hopital Saint Joseph Site Saint Michel | Paris | |
France | CHU Poitiers | Poitiers | |
France | Centre Hospitalier Rene Dubos | Pontoise | |
France | Clinique Armoricaine de Radiology | Saint Brieuc | |
France | Hopital Civil | Strasbourg | |
France | CHU Bretonneau | Tours | |
France | Centre Alexis Vautrin | Vandoeuvre les Nancy | |
Germany | Universitatsklinikum Aachen | Aachen | |
Germany | Charite Campus Mitte | Berlin | |
Germany | Krankenhaus Am Urban | Berlin | |
Germany | Universitatsklinikum Carl Gustav Carus An Der | Dresden | |
Germany | Klinikum der Johann Wolfgang Goethe-Universitat | Frankfurt am Main | |
Germany | Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz | Mainz | |
Germany | Klinikum Mannheim | Mannheim | |
Germany | Urologische Klinik und Poliklinik | Munchen | |
Italy | Fondazione IRCCS Ospedale Maggiore Policlinico | Milan | |
Italy | Fondazione San Raffaele del Monte Tabor | Milan | |
Italy | Istituto Europeo di Oncologia | Milan | |
Italy | Istituto Nazionale dei Tumori | Milano | |
Italy | Azienda Ospedaliero Universitaria di Modena | Modena | |
Italy | Azienda Ospedaliera Maggiore della Carita | Novarra | |
Italy | Azienda Ospedaliera di Parma | Parma | |
Italy | Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara | Pisa | |
Italy | Azienda Ospedaliera San Camillo Forlanini | Roma | |
Italy | Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata | Sassari | |
Italy | A.S.O. San Giovanni Battista di Torino | Turin | |
Netherlands | Academisch Centrum | Amsterdam | |
Netherlands | VU Medisch Centrum | Amsterdam | |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Bialystok | |
Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Bytom | |
Poland | Katedra i Klinika Onkologii i Radioterapli | Gdansk | |
Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Katowice | |
Poland | Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie | Krakow | |
Poland | Wojewodzki Szpital Specjalistyczny im. M. Kopernika | Lodz | |
Poland | Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu | Poznan | |
Poland | Wojewodzki Szpital Specjalistyczny w Siedlcach | Siedlce | |
Poland | Wojewodzki Szpital Specjalistyczny Oddzial Urologii | Slupsk | |
Poland | Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie | Warszawa | |
Poland | Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen | Warszawa | |
Sweden | Universitetssjukhuset i Lund | Lund | |
Sweden | University Hospital MAS (UMAS) | Malmo | |
Sweden | Akademiska Sjukhuset i Uppsala | Uppsala | |
United Kingdom | Addenbrookes Hospital | Cambridge | |
United Kingdom | Royal Surrey County Hospital | Guildford | |
United Kingdom | St. James University Hospital | Leeds | |
United Kingdom | Lincoln County Hospital | Lincoln | |
United Kingdom | Department of Oncology Hammersmith Hospital | London | |
United Kingdom | Royal Marsden Hospital | London | |
United Kingdom | Christie Hospital Manchester | Manchester | |
United Kingdom | Mount Vernon Hospital | Middlesex | |
United Kingdom | Nottingham City Hospital | Nottingham | |
United Kingdom | Rosemere Cancer Centre, Royal Preston Hospital | Preston | |
United Kingdom | Scunthorpe General Hospital, Dept of Oncology | Scunthorpe | |
United Kingdom | Royal Marsden Academic Urology Unit | Sutton | |
United Kingdom | Clatterbridge Centre For Oncology | Wirral | |
United States | New Mexico Oncology | Albuquerque | New Mexico |
United States | Alaska Clinical Research Center | Anchorage | Alaska |
United States | General Clinical Research Center University of Michigan | Ann Arbor | Michigan |
United States | Atlanta VA Medical Center | Atlanta | Georgia |
United States | Emory Winship Cancer Institute | Atlanta | Georgia |
United States | Peachtree Hematology & Oncology Consultants, PC | Atlanta | Georgia |
United States | Cancer Center and Department of Medicine | Aurora | Colorado |
United States | Billings Clinic | Billings | Montana |
United States | Gabrail Cancer Center | Canton | Ohio |
United States | Presbyterian Hospital Center for Cancer Research | Charlotte | North Carolina |
United States | Center for Oncology Research & Treatment, PA | Dallas | Texas |
United States | Dallas Oncology Consultants | Dallas | Texas |
United States | Mary Crowley Medical Research Center | Dallas | Texas |
United States | North Shore Hematology Oncology Associates P.C. | East Setauket | New York |
United States | St. Edward Mercy Medical Center | Fort Smith | Arkansas |
United States | Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland |
United States | Medical & Surgical Specialists | Galesburg | Illinois |
United States | Cancer Centers of the Carolinas | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Mobley Research Center | Houston | Texas |
United States | Northwest Cancer Center | Houston | Texas |
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Jupiter Hematology & Oncology Associates | Jupiter | Florida |
United States | Lakeland Regional Cancer Center | Lakeland | Florida |
United States | Nevada Cancer Institute | Las Vegas | Nevada |
United States | Loma Linda University | Loma Linda | California |
United States | Onocology Care Medical Associates | Los Angeles | California |
United States | James Graham Brown Cancer Center | Louisville | Kentucky |
United States | The West Clinic | Memphis | Tennessee |
United States | NYU Clinical Cancer Center | New York | New York |
United States | Hematology & Oncology Consultants P.C. | Omaha | Nebraska |
United States | Hematology Oncology Associates of the Treasure Coast | Port St. Lucie | Florida |
United States | Kaiser Permanente Oncology/Hematology | Portland | Oregon |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Desert Hematology Oncology Medical Group | Rancho Mirage | California |
United States | Urology San Antonio Research, PA | San Antonio | Texas |
United States | San Bernardino Urology Associates | San Bernardino | California |
United States | Kaiser Permanente Medical Group Dept. of Oncology Research | San Diego | California |
United States | Sharp Healthcare | San Diego | California |
United States | California Pacific Medical Center | San Francisco | California |
United States | UCSF Mt. Zion Cancer Center | San Francisco | California |
United States | Seattle Cancer Care Alliance, Univ. of Washington | Seattle | Washington |
United States | Cancer Research & Prevention Center | Soquel | California |
Lead Sponsor | Collaborator |
---|---|
Cell Genesys |
United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | 0 | No | |
Secondary | Time to disease progression. Time to pain progression. | 0 | No |
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