Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00133224
• Other study ID #: G-0034
• Secondary ID: VITAL-2
• Status: Terminated
• Phase: Phase 3
• First received: August 19, 2005
• Last updated: September 19, 2008
• Start date: July 2005
• Est. completion date: June 2009

Study information

• Verified date: September 2008
• Source: Cell Genesys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 408
• Est. completion date: June 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Drug:
• Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cell Genesys

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		0	No
Secondary	Time to disease progression. Time to pain progression.		0	No