Clinical trial NCT00133224: Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Advanced Prostate Cancer
HRPC
Prostate
Cancer
Metastatic
Hormone-refractory
GVAX
Chemotherapy
Taxotere
Docetaxel
Prednisone
Vaccine
Allogeneic cells
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-08-23
Enrollment: 408
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 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.


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
* 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

Primary outcomes:
measure: Survival
timeFrame: 0
Secondary outcomes:
measure: Time to disease progression. Time to pain progression.
timeFrame: 0
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Fort Smith
country: United States
facility: St. Edward Mercy Medical Center
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Los Angeles
country: United States
facility: Onocology Care Medical Associates
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urology Associates
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group Dept. of Oncology Research
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: San Francisco
country: United States
facility: UCSF Mt. Zion Cancer Center
state: California
city: Soquel
country: United States
facility: Cancer Research & Prevention Center
state: California
city: Aurora
country: United States
facility: Cancer Center and Department of Medicine
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Jupiter
country: United States
facility: Jupiter Hematology & Oncology Associates
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Hematology & Oncology Consultants, PC
state: Georgia
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Galesburg
country: United States
facility: Medical & Surgical Specialists
state: Illinois
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Frederick
country: United States
facility: Frederick Memorial Hospital Regional Cancer Therapy Center
state: Maryland
city: Ann Arbor
country: United States
facility: General Clinical Research Center University of Michigan
state: Michigan
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Omaha
country: United States
facility: Hematology & Oncology Consultants P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology
state: New Mexico
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates P.C.
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital Center for Cancer Research
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Oncology/Hematology
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Dallas
country: United States
facility: Center for Oncology Research & Treatment, PA
state: Texas
city: Dallas
country: United States
facility: Dallas Oncology Consultants
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
city: Houston
country: United States
facility: Northwest Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research, PA
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance, Univ. of Washington
state: Washington
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen - AZ Middelheim
city: Bonheiden
country: Belgium
facility: V.Z.W. Imelda Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHU de Liège - Hôpital du Sart Tilman
city: Roeselare
country: Belgium
facility: Heilig-Hartziekenhuis Campus Wilgenstraat
city: Sint Truiden
country: Belgium
facility: Regionaal Ziekenhuis Sint Trudo
city: Montreal
country: Canada
facility: Centre Hospitalier de L'Universite de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universite de Sherbrooke
state: Quebec
city: Angers
country: France
facility: Centre Regional de lutte contre le cancer Paul Papin
city: Caen
country: France
facility: Centre Francois Baclesse
city: Cedex
country: France
facility: Institut Jean Godinot, Oncologie Medicale
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne
city: Nantes
country: France
facility: Centre Rene Gauducheau - Site Hospitalier Nord
city: Nice
country: France
facility: Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer
city: Paris
country: France
facility: CHU Saint Louis
city: Paris
country: France
facility: Hopital Saint Joseph Site Saint Michel
city: Paris
country: France
facility: Hopital Cochin
city: Poitiers
country: France
facility: CHU Poitiers
city: Pontoise
country: France
facility: Centre Hospitalier Rene Dubos
city: Saint Brieuc
country: France
facility: Clinique Armoricaine de Radiology
city: Strasbourg
country: France
facility: Hopital Civil
city: Tours
country: France
facility: CHU Bretonneau
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
city: Aachen
country: Germany
facility: Universitatsklinikum Aachen
city: Berlin
country: Germany
facility: Charite Campus Mitte
city: Berlin
country: Germany
facility: Krankenhaus Am Urban
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus An Der
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitat
city: Mainz
country: Germany
facility: Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz
city: Mannheim
country: Germany
facility: Klinikum Mannheim
city: Munchen
country: Germany
facility: Urologische Klinik und Poliklinik
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico
city: Milan
country: Italy
facility: Fondazione San Raffaele del Monte Tabor
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena
city: Novarra
country: Italy
facility: Azienda Ospedaliera Maggiore della Carita
city: Parma
country: Italy
facility: Azienda Ospedaliera di Parma
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Sassari
country: Italy
facility: Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata
city: Turin
country: Italy
facility: A.S.O. San Giovanni Battista di Torino
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Academisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Bialystok
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Bytom
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Gdansk
country: Poland
facility: Katedra i Klinika Onkologii i Radioterapli
city: Katowice
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Krakow
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika
city: Poznan
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu
city: Siedlce
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Siedlcach
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny Oddzial Urologii
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie
city: Lund
country: Sweden
facility: Universitetssjukhuset i Lund
city: Malmo
country: Sweden
facility: University Hospital MAS (UMAS)
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset i Uppsala
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Leeds
country: United Kingdom
facility: St. James University Hospital
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: Department of Oncology Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital Manchester
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Preston
country: United Kingdom
facility: Rosemere Cancer Centre, Royal Preston Hospital
city: Scunthorpe
country: United Kingdom
facility: Scunthorpe General Hospital, Dept of Oncology
city: Sutton
country: United Kingdom
facility: Royal Marsden Academic Urology Unit
city: Wirral
country: United Kingdom
facility: Clatterbridge Centre For Oncology
Study officials:
References:
citation: 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.