Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
This study has been terminated.
(Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.)
Sponsor:
Cell Genesys
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00133224
First received: August 19, 2005
Last updated: September 19, 2008
Last verified: September 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel and prednisone) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cell Genesys:
Primary Outcome Measures:
- Survival [ Time Frame: 0 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to disease progression. Time to pain progression. [ Time Frame: 0 ] [ Designated as safety issue: No ]
| Enrollment: | 408 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
|
| 2 |
Drug: Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133224
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Hide Study LocationsLocations
| United States, Alaska | |
| Alaska Clinical Research Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arkansas | |
| St. Edward Mercy Medical Center | |
| Fort Smith, Arkansas, United States, 72917 | |
| United States, California | |
| Loma Linda University | |
| Loma Linda, California, United States, 92354 | |
| Onocology Care Medical Associates | |
| Los Angeles, California, United States, 90057 | |
| Desert Hematology Oncology Medical Group | |
| Rancho Mirage, California, United States, 92270 | |
| San Bernardino Urology Associates | |
| San Bernardino, California, United States, 92404 | |
| Sharp Healthcare | |
| San Diego, California, United States, 92123 | |
| Kaiser Permanente Medical Group Dept. of Oncology Research | |
| San Diego, California, United States, 92120 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| UCSF Mt. Zion Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Cancer Research & Prevention Center | |
| Soquel, California, United States, 95073 | |
| United States, Colorado | |
| Cancer Center and Department of Medicine | |
| Aurora, Colorado, United States, 80010 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| Jupiter Hematology & Oncology Associates | |
| Jupiter, Florida, United States, 33458 | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33804 | |
| Hematology Oncology Associates of the Treasure Coast | |
| Port St. Lucie, Florida, United States, 34952 | |
| United States, Georgia | |
| Peachtree Hematology & Oncology Consultants, PC | |
| Atlanta, Georgia, United States, 30309 | |
| Emory Winship Cancer Institute | |
| Atlanta, Georgia, United States, 30322 | |
| Atlanta VA Medical Center | |
| Atlanta, Georgia, United States, 30033 | |
| United States, Illinois | |
| Medical & Surgical Specialists | |
| Galesburg, Illinois, United States, 61401 | |
| United States, Kentucky | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Frederick Memorial Hospital Regional Cancer Therapy Center | |
| Frederick, Maryland, United States, 21701 | |
| United States, Michigan | |
| General Clinical Research Center University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Montana | |
| Billings Clinic | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Hematology & Oncology Consultants P.C. | |
| Omaha, Nebraska, United States, 68122 | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| New Mexico Oncology | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| North Shore Hematology Oncology Associates P.C. | |
| East Setauket, New York, United States, 11733 | |
| NYU Clinical Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Presbyterian Hospital Center for Cancer Research | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Gabrail Cancer Center | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| Kaiser Permanente Oncology/Hematology | |
| Portland, Oregon, United States, 97227 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Tennessee | |
| The West Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Center for Oncology Research & Treatment, PA | |
| Dallas, Texas, United States, 75230 | |
| Mary Crowley Medical Research Center | |
| Dallas, Texas, United States, 75246 | |
| Dallas Oncology Consultants | |
| Dallas, Texas, United States, 75237 | |
| Northwest Cancer Center | |
| Houston, Texas, United States, 77042 | |
| Mobley Research Center | |
| Houston, Texas, United States, 77024 | |
| Urology San Antonio Research, PA | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Seattle Cancer Care Alliance, Univ. of Washington | |
| Seattle, Washington, United States, 98109 | |
| Belgium | |
| Ziekenhuis Netwerk Antwerpen - AZ Middelheim | |
| Antwerpen, Belgium, B-2020 | |
| V.Z.W. Imelda Ziekenhuis | |
| Bonheiden, Belgium, B-2820 | |
| AZ Groeninge | |
| Kortrijk, Belgium, B-8500 | |
| CHU de Liège - Hôpital du Sart Tilman | |
| Liège, Belgium, B-4000 | |
| Heilig-Hartziekenhuis Campus Wilgenstraat | |
| Roeselare, Belgium, B- 8800 | |
| Regionaal Ziekenhuis Sint Trudo | |
| Sint Truiden, Belgium, B-3800 | |
| Canada, Quebec | |
| Centre Hospitalier de L'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Centre Hospitalier Universite de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| France | |
| Centre Regional de lutte contre le cancer Paul Papin | |
| Angers, France, 49033 | |
| Centre Francois Baclesse | |
| Caen, France, 14076 | |
| Institut Jean Godinot, Oncologie Medicale | |
| Cedex, France, 51056 | |
| Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne | |
| Clermont-Ferrand, France, 63011 | |
| Centre Rene Gauducheau - Site Hospitalier Nord | |
| Nantes, France, 44805 | |
| Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer | |
| Nice, France, 06189 | |
| CHU Saint Louis | |
| Paris, France, 75010 | |
| Hopital Cochin | |
| Paris, France, 75674 | |
| Hopital Saint Joseph Site Saint Michel | |
| Paris, France, 75015 | |
| CHU Poitiers | |
| Poitiers, France, 86021 | |
| Centre Hospitalier Rene Dubos | |
| Pontoise, France, 95303 | |
| Clinique Armoricaine de Radiology | |
| Saint Brieuc, France, 22015 | |
| Hopital Civil | |
| Strasbourg, France, 67091 | |
| CHU Bretonneau | |
| Tours, France, 37044 | |
| Centre Alexis Vautrin | |
| Vandoeuvre les Nancy, France, 54500 | |
| Germany | |
| Universitatsklinikum Aachen | |
| Aachen, Germany, 52074 | |
| Charite Campus Mitte | |
| Berlin, Germany, 10117 | |
| Krankenhaus Am Urban | |
| Berlin, Germany, 10967 | |
| Universitatsklinikum Carl Gustav Carus An Der | |
| Dresden, Germany, 01307 | |
| Klinikum der Johann Wolfgang Goethe-Universitat | |
| Frankfurt am Main, Germany, 60590 | |
| Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz | |
| Mainz, Germany, 55131 | |
| Klinikum Mannheim | |
| Mannheim, Germany, 68135 | |
| Urologische Klinik und Poliklinik | |
| Munchen, Germany, 81675 | |
| Italy | |
| Fondazione IRCCS Ospedale Maggiore Policlinico | |
| Milan, Italy, 20122 | |
| Fondazione San Raffaele del Monte Tabor | |
| Milan, Italy, 20132 | |
| Istituto Europeo di Oncologia | |
| Milan, Italy, 20141 | |
| Istituto Nazionale dei Tumori | |
| Milano, Italy, 20133 | |
| Azienda Ospedaliero Universitaria di Modena | |
| Modena, Italy, 41100 | |
| Azienda Ospedaliera Maggiore della Carita | |
| Novarra, Italy, 28100 | |
| Azienda Ospedaliera di Parma | |
| Parma, Italy, 43100 | |
| Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara | |
| Pisa, Italy, 56126 | |
| Azienda Ospedaliera San Camillo Forlanini | |
| Roma, Italy, 00152 | |
| Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata | |
| Sassari, Italy, 07100 | |
| A.S.O. San Giovanni Battista di Torino | |
| Turin, Italy, 10126 | |
| Netherlands | |
| VU Medisch Centrum | |
| Amsterdam, Netherlands, 1081 HV | |
| Academisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| Universitair Medisch Centrum Groningen | |
| Groningen, Netherlands, 9713 GZ | |
| Poland | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej | |
| Bialystok, Poland, 15-950 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej | |
| Bytom, Poland, 41-902 | |
| Katedra i Klinika Onkologii i Radioterapli | |
| Gdansk, Poland, 80-952 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej | |
| Katowice, Poland, 40-073 | |
| Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie | |
| Krakow, Poland, 31-115 | |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika | |
| Lodz, Poland, 93-509 | |
| Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu | |
| Poznan, Poland, 61-848 | |
| Wojewodzki Szpital Specjalistyczny w Siedlcach | |
| Siedlce, Poland, 08-110 | |
| Wojewodzki Szpital Specjalistyczny Oddzial Urologii | |
| Slupsk, Poland, 76-200 | |
| Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie | |
| Warszawa, Poland, 02-781 | |
| Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen | |
| Warszawa, Poland, 02-005 | |
| Sweden | |
| Universitetssjukhuset i Lund | |
| Lund, Sweden, SE-22185 | |
| University Hospital MAS (UMAS) | |
| Malmo, Sweden, SE-205 02 | |
| Akademiska Sjukhuset i Uppsala | |
| Uppsala, Sweden, SE-75185 | |
| United Kingdom | |
| Addenbrookes Hospital | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Royal Surrey County Hospital | |
| Guildford, United Kingdom, GU2 7XX | |
| St. James University Hospital | |
| Leeds, United Kingdom, LS9 7TF | |
| Lincoln County Hospital | |
| Lincoln, United Kingdom, LN2 4AX | |
| Royal Marsden Hospital | |
| London, United Kingdom, SW3 6JJ | |
| Department of Oncology Hammersmith Hospital | |
| London, United Kingdom, W12 0NN | |
| Christie Hospital Manchester | |
| Manchester, United Kingdom, M20 4BX | |
| Mount Vernon Hospital | |
| Middlesex, United Kingdom, HA6 2RN | |
| Nottingham City Hospital | |
| Nottingham, United Kingdom, NG5 1PB | |
| Rosemere Cancer Centre, Royal Preston Hospital | |
| Preston, United Kingdom, PR2 9HT | |
| Scunthorpe General Hospital, Dept of Oncology | |
| Scunthorpe, United Kingdom, DN15 7BH | |
| Royal Marsden Academic Urology Unit | |
| Sutton, United Kingdom, SM2 5PT | |
| Clatterbridge Centre For Oncology | |
| Wirral, United Kingdom, CH63 4JY | |
Sponsors and Collaborators
Cell Genesys
More Information
No publications provided by Cell Genesys
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cell Genesys, Inc. |
| ClinicalTrials.gov Identifier: | NCT00133224 History of Changes |
| Other Study ID Numbers: | G-0034, VITAL-2 |
| Study First Received: | August 19, 2005 |
| Last Updated: | September 19, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cell Genesys:
|
Advanced Prostate Cancer HRPC Prostate Cancer Metastatic Hormone-refractory GVAX |
Chemotherapy Taxotere Docetaxel Prednisone Vaccine Allogeneic cells |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Prednisone Docetaxel |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013