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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. )
First Received: August 19, 2005   Last Updated: September 19, 2008   History of Changes
Sponsor: Cell Genesys
Information provided by: Cell Genesys
ClinicalTrials.gov Identifier: NCT00133224
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental 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

  Hide Study Locations
Locations
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
Cancer Research & Prevention Center
Soquel, California, United States, 95073
Onocology Care Medical Associates
Los Angeles, California, United States, 90057
Kaiser Permanente Medical Group Dept. of Oncology Research
San Diego, California, United States, 92120
Loma Linda University
Loma Linda, California, United States, 92354
Sharp Healthcare
San Diego, California, United States, 92123
UCSF Mt. Zion Cancer Center
San Francisco, California, United States, 94115
California Pacific Medical Center
San Francisco, California, United States, 94115
San Bernardino Urology Associates
San Bernardino, California, United States, 92404
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
United States, Colorado
Cancer Center and Department of Medicine
Aurora, Colorado, United States, 80010
United States, Florida
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33804
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Jupiter Hematology & Oncology Associates
Jupiter, Florida, United States, 33458
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
Mobley Research Center
Houston, Texas, United States, 77024
Dallas Oncology Consultants
Dallas, Texas, United States, 75237
Northwest Cancer Center
Houston, Texas, United States, 77042
Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
United States, Washington
Seattle Cancer Care Alliance, Univ. of Washington
Seattle, Washington, United States, 98109
Belgium
CHU de Liège - Hôpital du Sart Tilman
Liège, Belgium, B-4000
AZ Groeninge
Kortrijk, Belgium, B-8500
Ziekenhuis Netwerk Antwerpen - AZ Middelheim
Antwerpen, Belgium, B-2020
Heilig-Hartziekenhuis Campus Wilgenstraat
Roeselare, Belgium, B- 8800
Regionaal Ziekenhuis Sint Trudo
Sint Truiden, Belgium, B-3800
V.Z.W. Imelda Ziekenhuis
Bonheiden, Belgium, B-2820
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
Hopital Civil
Strasbourg, France, 67091
Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer
Nice, France, 06189
CHU Saint Louis
Paris, France, 75010
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54500
Clinique Armoricaine de Radiology
Saint Brieuc, France, 22015
Centre Rene Gauducheau - Site Hospitalier Nord
Nantes, France, 44805
Centre Hospitalier Rene Dubos
Pontoise, France, 95303
CHU Poitiers
Poitiers, France, 86021
Centre Francois Baclesse
Caen, France, 14076
CHU Bretonneau
Tours, France, 37044
Hopital Cochin
Paris, France, 75674
Hopital Saint Joseph Site Saint Michel
Paris, France, 75015
Institut Jean Godinot, Oncologie Medicale
Cedex, France, 51056
Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne
Clermont-Ferrand, France, 63011
Germany
Universitatsklinikum Aachen
Aachen, Germany, 52074
Charite Campus Mitte
Berlin, Germany, 10117
Krankenhaus Am Urban
Berlin, Germany, 10967
Urologische Klinik und Poliklinik
Munchen, Germany, 81675
Universitatsklinikum Carl Gustav Carus An Der
Dresden, Germany, 01307
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt am Main, Germany, 60590
Klinikum Mannheim
Mannheim, Germany, 68135
Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz
Mainz, Germany, 55131
Italy
Istituto Nazionale dei Tumori
Milano, Italy, 20133
Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata
Sassari, Italy, 07100
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, Italy, 20122
Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara
Pisa, Italy, 56126
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
A.S.O. San Giovanni Battista di Torino
Turin, Italy, 10126
Istituto Europeo di Oncologia
Milan, Italy, 20141
Azienda Ospedaliera Maggiore della Carita
Novarra, Italy, 28100
Azienda Ospedaliero Universitaria di Modena
Modena, Italy, 41100
Azienda Ospedaliera di Parma
Parma, Italy, 43100
Fondazione San Raffaele del Monte Tabor
Milan, Italy, 20132
Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Academisch Centrum
Amsterdam, Netherlands, 1105 AZ
VU Medisch Centrum
Amsterdam, Netherlands, 1081 HV
Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie
Warszawa, Poland, 02-781
Wojewodzki Szpital Specjalistyczny Oddzial Urologii
Slupsk, Poland, 76-200
Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu
Poznan, Poland, 61-848
Katedra i Klinika Onkologii i Radioterapli
Gdansk, Poland, 80-952
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie
Krakow, Poland, 31-115
Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen
Warszawa, Poland, 02-005
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bytom, Poland, 41-902
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, Poland, 93-509
Wojewodzki Szpital Specjalistyczny w Siedlcach
Siedlce, Poland, 08-110
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bialystok, Poland, 15-950
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Katowice, Poland, 40-073
Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, Sweden, SE-75185
Universitetssjukhuset i Lund
Lund, Sweden, SE-22185
University Hospital MAS (UMAS)
Malmo, Sweden, SE-205 02
United Kingdom
Royal Marsden Academic Urology Unit
Sutton, United Kingdom, SM2 5PT
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 2QQ
Mount Vernon Hospital
Middlesex, United Kingdom, HA6 2RN
Rosemere Cancer Centre, Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
St. James University Hospital
Leeds, United Kingdom, LS9 7TF
Scunthorpe General Hospital, Dept of Oncology
Scunthorpe, United Kingdom, DN15 7BH
Lincoln County Hospital
Lincoln, United Kingdom, LN2 4AX
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Clatterbridge Centre For Oncology
Wirral, United Kingdom, CH63 4JY
Christie Hospital Manchester
Manchester, United Kingdom, M20 4BX
Department of Oncology Hammersmith Hospital
London, United Kingdom, W12 0NN
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Cell Genesys
  More Information

No publications provided

Responsible Party: Cell Genesys, Inc. ( Cell Genesys, Inc. )
Study ID Numbers: G-0034, VITAL-2
Study First Received: August 19, 2005
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00133224     History of Changes
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:
Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009