Study Stopped
Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
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
2 other identifiers
interventional
408
10 countries
115
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Jul 2005
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 19, 2005
CompletedFirst Posted
Study publicly available on registry
August 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedSeptember 23, 2008
September 1, 2008
3.1 years
August 19, 2005
September 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
0
Secondary Outcomes (1)
Time to disease progression. Time to pain progression.
0
Study Arms (2)
1
EXPERIMENTAL2
OTHERInterventions
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cell Genesyslead
Study Sites (115)
Alaska Clinical Research Center
Anchorage, Alaska, 99508, United States
St. Edward Mercy Medical Center
Fort Smith, Arkansas, 72917, United States
Loma Linda University
Loma Linda, California, 92354, United States
Onocology Care Medical Associates
Los Angeles, California, 90057, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270, United States
San Bernardino Urology Associates
San Bernardino, California, 92404, United States
Kaiser Permanente Medical Group Dept. of Oncology Research
San Diego, California, 92120, United States
Sharp Healthcare
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
UCSF Mt. Zion Cancer Center
San Francisco, California, 94115, United States
Cancer Research & Prevention Center
Soquel, California, 95073, United States
Cancer Center and Department of Medicine
Aurora, Colorado, 80010, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Jupiter Hematology & Oncology Associates
Jupiter, Florida, 33458, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33804, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Atlanta VA Medical Center
Atlanta, Georgia, 30033, United States
Peachtree Hematology & Oncology Consultants, PC
Atlanta, Georgia, 30309, United States
Emory Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Medical & Surgical Specialists
Galesburg, Illinois, 61401, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, 21701, United States
General Clinical Research Center University of Michigan
Ann Arbor, Michigan, 48109, United States
Billings Clinic
Billings, Montana, 59101, United States
Hematology & Oncology Consultants P.C.
Omaha, Nebraska, 68122, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New Mexico Oncology
Albuquerque, New Mexico, 87109, United States
North Shore Hematology Oncology Associates P.C.
East Setauket, New York, 11733, United States
NYU Clinical Cancer Center
New York, New York, 10016, United States
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, 28204, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Kaiser Permanente Oncology/Hematology
Portland, Oregon, 97227, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Center for Oncology Research & Treatment, PA
Dallas, Texas, 75230, United States
Dallas Oncology Consultants
Dallas, Texas, 75237, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Mobley Research Center
Houston, Texas, 77024, United States
Northwest Cancer Center
Houston, Texas, 77042, United States
Urology San Antonio Research, PA
San Antonio, Texas, 78229, United States
Seattle Cancer Care Alliance, Univ. of Washington
Seattle, Washington, 98109, United States
Ziekenhuis Netwerk Antwerpen - AZ Middelheim
Antwerp, B-2020, Belgium
V.Z.W. Imelda Ziekenhuis
Bonheiden, B-2820, Belgium
AZ Groeninge
Kortrijk, B-8500, Belgium
CHU de Liège - Hôpital du Sart Tilman
Liège, B-4000, Belgium
Heilig-Hartziekenhuis Campus Wilgenstraat
Roeselare, B- 8800, Belgium
Regionaal Ziekenhuis Sint Trudo
Sint-Truiden, B-3800, Belgium
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, H2L 4M1, Canada
Centre Hospitalier Universite de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Centre Regional de lutte contre le cancer Paul Papin
Angers, 49033, France
Centre Francois Baclesse
Caen, 14076, France
Institut Jean Godinot, Oncologie Medicale
Cedex, 51056, France
Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne
Clermont-Ferrand, 63011, France
Centre Rene Gauducheau - Site Hospitalier Nord
Nantes, 44805, France
Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer
Nice, 06189, France
CHU Saint Louis
Paris, 75010, France
Hopital Saint Joseph Site Saint Michel
Paris, 75015, France
Hopital Cochin
Paris, 75674, France
CHU Poitiers
Poitiers, 86021, France
Centre Hospitalier Rene Dubos
Pontoise, 95303, France
Clinique Armoricaine de Radiology
Saint-Brieuc, 22015, France
Hopital Civil
Strasbourg, 67091, France
CHU Bretonneau
Tours, 37044, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
Universitatsklinikum Aachen
Aachen, 52074, Germany
Charite Campus Mitte
Berlin, 10117, Germany
Krankenhaus Am Urban
Berlin, 10967, Germany
Universitatsklinikum Carl Gustav Carus An Der
Dresden, 01307, Germany
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt am Main, 60590, Germany
Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz
Mainz, 55131, Germany
Klinikum Mannheim
Mannheim, 68135, Germany
Urologische Klinik und Poliklinik
München, 81675, Germany
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, 20122, Italy
Fondazione San Raffaele del Monte Tabor
Milan, 20132, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliero Universitaria di Modena
Modena, 41100, Italy
Azienda Ospedaliera Maggiore della Carita
Novarra, 28100, Italy
Azienda Ospedaliera di Parma
Parma, 43100, Italy
Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara
Pisa, 56126, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata
Sassari, 07100, Italy
A.S.O. San Giovanni Battista di Torino
Turin, 10126, Italy
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Academisch Centrum
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bialystok, 15-950, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bytom, 41-902, Poland
Katedra i Klinika Onkologii i Radioterapli
Gdansk, 80-952, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Katowice, 40-073, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie
Krakow, 31-115, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, 93-509, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu
Poznan, 61-848, Poland
Wojewodzki Szpital Specjalistyczny w Siedlcach
Siedlce, 08-110, Poland
Wojewodzki Szpital Specjalistyczny Oddzial Urologii
Słupsk, 76-200, Poland
Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen
Warsaw, 02-005, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie
Warsaw, 02-781, Poland
Universitetssjukhuset i Lund
Lund, SE-22185, Sweden
University Hospital MAS (UMAS)
Malmo, SE-205 02, Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, SE-75185, Sweden
Addenbrookes Hospital
Cambridge, CB2 2QQ, United Kingdom
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
St. James University Hospital
Leeds, LS9 7TF, United Kingdom
Lincoln County Hospital
Lincoln, LN2 4AX, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Department of Oncology Hammersmith Hospital
London, W12 0NN, United Kingdom
Christie Hospital Manchester
Manchester, M20 4BX, United Kingdom
Clatterbridge Centre For Oncology
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Mount Vernon Hospital
Middlesex, HA6 2RN, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Rosemere Cancer Centre, Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Scunthorpe General Hospital, Dept of Oncology
Scunthorpe, DN15 7BH, United Kingdom
Royal Marsden Academic Urology Unit
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Michael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010:bcr11.2009.2495. doi: 10.1136/bcr.11.2009.2495.
PMID: 22736604DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 19, 2005
First Posted
August 23, 2005
Study Start
July 1, 2005
Primary Completion
August 1, 2008
Study Completion
June 1, 2009
Last Updated
September 23, 2008
Record last verified: 2008-09