Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
Sponsor
Cell Genesys (Industry)
Overall Status
Terminated
CT.gov ID
NCT00133224
Collaborator
(none)
408
115
2
47
3.5
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
408 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date
:
Jul 1, 2005
Actual Primary Completion Date
:
Aug 1, 2008
Anticipated Study Completion Date
:
Jun 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
|
| Other: 2
|
Drug: Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
|
Outcome Measures
Primary Outcome Measures
- Survival [0]
Secondary Outcome Measures
- Time to disease progression. Time to pain progression. [0]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Clinical Research Center | Anchorage | Alaska | United States | 99508 |
| 2 | St. Edward Mercy Medical Center | Fort Smith | Arkansas | United States | 72917 |
| 3 | Loma Linda University | Loma Linda | California | United States | 92354 |
| 4 | Onocology Care Medical Associates | Los Angeles | California | United States | 90057 |
| 5 | Desert Hematology Oncology Medical Group | Rancho Mirage | California | United States | 92270 |
| 6 | San Bernardino Urology Associates | San Bernardino | California | United States | 92404 |
| 7 | Kaiser Permanente Medical Group Dept. of Oncology Research | San Diego | California | United States | 92120 |
| 8 | Sharp Healthcare | San Diego | California | United States | 92123 |
| 9 | California Pacific Medical Center | San Francisco | California | United States | 94115 |
| 10 | UCSF Mt. Zion Cancer Center | San Francisco | California | United States | 94115 |
| 11 | Cancer Research & Prevention Center | Soquel | California | United States | 95073 |
| 12 | Cancer Center and Department of Medicine | Aurora | Colorado | United States | 80010 |
| 13 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
| 14 | Jupiter Hematology & Oncology Associates | Jupiter | Florida | United States | 33458 |
| 15 | Lakeland Regional Cancer Center | Lakeland | Florida | United States | 33804 |
| 16 | Hematology Oncology Associates of the Treasure Coast | Port St. Lucie | Florida | United States | 34952 |
| 17 | Atlanta VA Medical Center | Atlanta | Georgia | United States | 30033 |
| 18 | Peachtree Hematology & Oncology Consultants, PC | Atlanta | Georgia | United States | 30309 |
| 19 | Emory Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 20 | Medical & Surgical Specialists | Galesburg | Illinois | United States | 61401 |
| 21 | James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 22 | Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland | United States | 21701 |
| 23 | General Clinical Research Center University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 24 | Billings Clinic | Billings | Montana | United States | 59101 |
| 25 | Hematology & Oncology Consultants P.C. | Omaha | Nebraska | United States | 68122 |
| 26 | Nevada Cancer Institute | Las Vegas | Nevada | United States | 89135 |
| 27 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 28 | New Mexico Oncology | Albuquerque | New Mexico | United States | 87109 |
| 29 | North Shore Hematology Oncology Associates P.C. | East Setauket | New York | United States | 11733 |
| 30 | NYU Clinical Cancer Center | New York | New York | United States | 10016 |
| 31 | Presbyterian Hospital Center for Cancer Research | Charlotte | North Carolina | United States | 28204 |
| 32 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 33 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 34 | Kaiser Permanente Oncology/Hematology | Portland | Oregon | United States | 97227 |
| 35 | Cancer Centers of the Carolinas | Greenville | South Carolina | United States | 29605 |
| 36 | The West Clinic | Memphis | Tennessee | United States | 38120 |
| 37 | Center for Oncology Research & Treatment, PA | Dallas | Texas | United States | 75230 |
| 38 | Dallas Oncology Consultants | Dallas | Texas | United States | 75237 |
| 39 | Mary Crowley Medical Research Center | Dallas | Texas | United States | 75246 |
| 40 | Mobley Research Center | Houston | Texas | United States | 77024 |
| 41 | Northwest Cancer Center | Houston | Texas | United States | 77042 |
| 42 | Urology San Antonio Research, PA | San Antonio | Texas | United States | 78229 |
| 43 | Seattle Cancer Care Alliance, Univ. of Washington | Seattle | Washington | United States | 98109 |
| 44 | Ziekenhuis Netwerk Antwerpen - AZ Middelheim | Antwerpen | Belgium | B-2020 | |
| 45 | V.Z.W. Imelda Ziekenhuis | Bonheiden | Belgium | B-2820 | |
| 46 | AZ Groeninge | Kortrijk | Belgium | B-8500 | |
| 47 | CHU de Liège - Hôpital du Sart Tilman | Liège | Belgium | B-4000 | |
| 48 | Heilig-Hartziekenhuis Campus Wilgenstraat | Roeselare | Belgium | B- 8800 | |
| 49 | Regionaal Ziekenhuis Sint Trudo | Sint Truiden | Belgium | B-3800 | |
| 50 | Centre Hospitalier de L'Universite de Montreal | Montreal | Quebec | Canada | H2L 4M1 |
| 51 | Centre Hospitalier Universite de Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 52 | Centre Regional de lutte contre le cancer Paul Papin | Angers | France | 49033 | |
| 53 | Centre Francois Baclesse | Caen | France | 14076 | |
| 54 | Institut Jean Godinot, Oncologie Medicale | Cedex | France | 51056 | |
| 55 | Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne | Clermont-Ferrand | France | 63011 | |
| 56 | Centre Rene Gauducheau - Site Hospitalier Nord | Nantes | France | 44805 | |
| 57 | Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer | Nice | France | 06189 | |
| 58 | CHU Saint Louis | Paris | France | 75010 | |
| 59 | Hopital Saint Joseph Site Saint Michel | Paris | France | 75015 | |
| 60 | Hopital Cochin | Paris | France | 75674 | |
| 61 | CHU Poitiers | Poitiers | France | 86021 | |
| 62 | Centre Hospitalier Rene Dubos | Pontoise | France | 95303 | |
| 63 | Clinique Armoricaine de Radiology | Saint Brieuc | France | 22015 | |
| 64 | Hopital Civil | Strasbourg | France | 67091 | |
| 65 | CHU Bretonneau | Tours | France | 37044 | |
| 66 | Centre Alexis Vautrin | Vandoeuvre les Nancy | France | 54500 | |
| 67 | Universitatsklinikum Aachen | Aachen | Germany | 52074 | |
| 68 | Charite Campus Mitte | Berlin | Germany | 10117 | |
| 69 | Krankenhaus Am Urban | Berlin | Germany | 10967 | |
| 70 | Universitatsklinikum Carl Gustav Carus An Der | Dresden | Germany | 01307 | |
| 71 | Klinikum der Johann Wolfgang Goethe-Universitat | Frankfurt am Main | Germany | 60590 | |
| 72 | Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz | Mainz | Germany | 55131 | |
| 73 | Klinikum Mannheim | Mannheim | Germany | 68135 | |
| 74 | Urologische Klinik und Poliklinik | Munchen | Germany | 81675 | |
| 75 | Istituto Nazionale dei Tumori | Milano | Italy | 20133 | |
| 76 | Fondazione IRCCS Ospedale Maggiore Policlinico | Milan | Italy | 20122 | |
| 77 | Fondazione San Raffaele del Monte Tabor | Milan | Italy | 20132 | |
| 78 | Istituto Europeo di Oncologia | Milan | Italy | 20141 | |
| 79 | Azienda Ospedaliero Universitaria di Modena | Modena | Italy | 41100 | |
| 80 | Azienda Ospedaliera Maggiore della Carita | Novarra | Italy | 28100 | |
| 81 | Azienda Ospedaliera di Parma | Parma | Italy | 43100 | |
| 82 | Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara | Pisa | Italy | 56126 | |
| 83 | Azienda Ospedaliera San Camillo Forlanini | Roma | Italy | 00152 | |
| 84 | Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata | Sassari | Italy | 07100 | |
| 85 | A.S.O. San Giovanni Battista di Torino | Turin | Italy | 10126 | |
| 86 | VU Medisch Centrum | Amsterdam | Netherlands | 1081 HV | |
| 87 | Academisch Centrum | Amsterdam | Netherlands | 1105 AZ | |
| 88 | Universitair Medisch Centrum Groningen | Groningen | Netherlands | 9713 GZ | |
| 89 | Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Bialystok | Poland | 15-950 | |
| 90 | Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Bytom | Poland | 41-902 | |
| 91 | Katedra i Klinika Onkologii i Radioterapli | Gdansk | Poland | 80-952 | |
| 92 | Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Katowice | Poland | 40-073 | |
| 93 | Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie | Krakow | Poland | 31-115 | |
| 94 | Wojewodzki Szpital Specjalistyczny im. M. Kopernika | Lodz | Poland | 93-509 | |
| 95 | Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu | Poznan | Poland | 61-848 | |
| 96 | Wojewodzki Szpital Specjalistyczny w Siedlcach | Siedlce | Poland | 08-110 | |
| 97 | Wojewodzki Szpital Specjalistyczny Oddzial Urologii | Slupsk | Poland | 76-200 | |
| 98 | Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen | Warszawa | Poland | 02-005 | |
| 99 | Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie | Warszawa | Poland | 02-781 | |
| 100 | Universitetssjukhuset i Lund | Lund | Sweden | SE-22185 | |
| 101 | University Hospital MAS (UMAS) | Malmo | Sweden | SE-205 02 | |
| 102 | Akademiska Sjukhuset i Uppsala | Uppsala | Sweden | SE-75185 | |
| 103 | Addenbrookes Hospital | Cambridge | United Kingdom | CB2 2QQ | |
| 104 | Royal Surrey County Hospital | Guildford | United Kingdom | GU2 7XX | |
| 105 | St. James University Hospital | Leeds | United Kingdom | LS9 7TF | |
| 106 | Lincoln County Hospital | Lincoln | United Kingdom | LN2 4AX | |
| 107 | Royal Marsden Hospital | London | United Kingdom | SW3 6JJ | |
| 108 | Department of Oncology Hammersmith Hospital | London | United Kingdom | W12 0NN | |
| 109 | Christie Hospital Manchester | Manchester | United Kingdom | M20 4BX | |
| 110 | Mount Vernon Hospital | Middlesex | United Kingdom | HA6 2RN | |
| 111 | Nottingham City Hospital | Nottingham | United Kingdom | NG5 1PB | |
| 112 | Rosemere Cancer Centre, Royal Preston Hospital | Preston | United Kingdom | PR2 9HT | |
| 113 | Scunthorpe General Hospital, Dept of Oncology | Scunthorpe | United Kingdom | DN15 7BH | |
| 114 | Royal Marsden Academic Urology Unit | Sutton | United Kingdom | SM2 5PT | |
| 115 | Clatterbridge Centre For Oncology | Wirral | United Kingdom | CH63 4JY |
Sponsors and Collaborators
- Cell Genesys
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00133224
Other Study ID Numbers:
- G-0034
- VITAL-2
First Posted:
Aug 23, 2005
Last Update Posted:
Sep 23, 2008
Last Verified:
Sep 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: