Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

Prostate Cancer Clinical Trial

Official title:

A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069745
• Other study ID #: GPC SAT3-03-01
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2003
• Last updated: August 1, 2012
• Start date: September 2003
• Est. completion date: March 2007

Study information

• Verified date: August 2012
• Source: Agennix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

PURPOSE:

The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

TARGET PATIENT POPULATION:

The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.

RATIONALE:

There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2007
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage D2 metastatic prostate cancer

• Progression after one prior chemotherapy

• ECOG Performance status equal / less than 2

• Life expectancy > 3 months

• Surgical or medical castration

• Adequate bone marrow, hepatic and renal functions

• Informed consent

Exclusion Criteria:

• More than one prior chemotherapy

• Prior platinum containing compounds

• Prior malignancy

• Prior significant RT/radionuclide therapy

• Major GI surgery or GI disease affecting absorption

• Disease with contraindication to steroids

• Brain metastases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Satraplatin

• Prednisone

Locations

Country	Name	City	State
Argentina	Hospital Italiano Regional del Sur Dept. Oncology	Bahia Blanca
Argentina	Grupo Plaza Dept. Oncology	Belen de Escobar
Argentina	Instituto Alexander Fleming	Buenos Aires
Argentina	Instituto Quirúrgico del Callao	Buenos Aires
Argentina	Clinica Oncologica de Excelencia	Capital Federal	Buenos Aires
Argentina	Hospital General de Agudos E. Tornu	Capital Federal	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Capital Federal	Buenos Aires
Argentina	Policlinica Bancaria "9 de Julio" Av. Gaona 2197	Capital Federal	Buenos Aires
Argentina	Centro Oncológico LALCEC	Concepcion del Uruguay, Entre Ríos
Argentina	Hospital Italiano de Cordoba Dept. Oncology	Cordoba
Argentina	Unidad Oncologica del Neuquen	Neuquen
Argentina	Salisbury Investigaciones Clinicas del Grupo CER S.A.	Quilmes	Buenos Aires
Argentina	Caici Dept. Oncology	Rosario
Argentina	Centro Oncologico Rosario	Rosario
Argentina	Centro San Roque	San Miguel de Tucumán, Tucumán
Argentina	Clinical Especializada ISIS	Santa Fe
Belgium	AZ-VUB	Bruxelles
Belgium	Hopital Erasme	Bruxelles
Belgium	Institut Jules Bordet Service de Chimiothérapie	Bruxelles
Belgium	UCLC St. Luc	Bruxelles
Belgium	Sint Maartenziekenhuis	Kortrijk
Croatia	Clinical Hospital Split Department of Oncology and Radiotherapy	Split
Croatia	Clinical Hostpital Rebro Department of Oncology	Zagreb
France	Institut Bergonié	Bordeaux Cedex
France	Centre Georges François Leclerc	Dijon
France	Clinique du Mail Service d'Oncologie	Grenoble
France	Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie	Grenoble Cedex 09
France	Centre Hospitalier Départemental	La Roche Sur Yon
France	CHU de Bicêtre	Le Kremlin Bicetre
France	Chu Dupuytren	Limoges
France	CRLC Léon Bérard	Lyon
France	Centre Hospitalier Belfort-Montbeliard	Montbeliard
France	CRLC Val d'Aurelle Paul-Lamarque	Montpellier
France	Centre Antoine Lacassagne Oncologie medicale	Nice Cedex 2
France	Hôpital Saint-Louis: Service de Radiotherapy	Paris
France	Hôpital Tenon	Paris
France	CHU de Poitiers	Poitiers
France	Institut Jean , Service d'Oncologie	Reims
France	Centre Eugene Marquis	Rennes Cedex
France	Centre Alexis Vautrin	Vandoeuvre Les Nancy
Germany	RWTH Aachen	Aachen
Germany	Fach- und Belegarzte fur Urologie	Berlin
Germany	Vivantes Krankenhaus am Urban	Berlin
Germany	Diakonissenkrankenhaus Dessau gGmbH	Dessau
Germany	Universitätsklinikum der Carl-Gustav-Carus Universität	Dresden
Germany	Stadtische Klinicen Frankfurt a.M. Hochst	Frankfurt a.M. Hochst
Germany	EuromedClinic	Fürth
Germany	Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg	Halle
Germany	Niedergelassener Urologe	Hamburg
Germany	Medizinische Hochschule	Hannover
Germany	Marienhospital II	Herne
Germany	Universitatklinikum Schleswig-Holstein	Lubeck
Germany	Klinickum der Johannes-Gutenberg Universitat	Mainz
Germany	Klinikum der Philipps - Universitat Marburg	Marburg
Germany	Klinikum rechts der Isar	München
Germany	Universitatklinikum Munster	Munster
Germany	Klinik Bad Trissel	Oberaudorf
Germany	Urologische Praxis	Saarbrücken
Hungary	National Institute of Oncology	Budapest
Hungary	St. Istvan Hospital	Budapest
Hungary	St. Margit Hospital	Budapest
Hungary	Pecs Medical University	Pecs
Israel	Soroka Medical Center	Beerhseva
Israel	Rambam Medical Center	Haifa
Israel	Hadassah University	Jerusalem
Israel	Hospital Ein Kerem Asaf Harofeh Medical Center	Zerifin
Italy	Istituto Nazionale per la Ricerca sul Cancro (IST)	Genoa
Italy	Universita degli Studi di Napoli Federico II-Nuovo Policlinico	Napoli
Italy	A.S.O. San Luigi	Orbassano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	A.O. San Camillo-Forlanini	Rome
Italy	Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia	Rozanno (MI)
Netherlands	Academic Hospital of the University of Amsterdam	Amsterdam
Netherlands	Academisch Ziekenhuis Nijmegen: Urology Department	Nijmegen
Netherlands	Streekziekenhuis Koningin : Dept. Urology	Winterswijk
Peru	Essalud Dept. Oncology	Jesus Maria
Peru	INEN Dept Onco-Hemato	Lima
Peru	San Felipe (Oncomedical)	Lima
Poland	Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny	Bialystok
Poland	Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK	Gdynia
Poland	Akademia Medyczna w Lodzi	Lodz
Poland	Akademia Medyczna w Lublinie	Lublin
Poland	Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut	Poznan
Poland	Akademia Medyczna w Szczecinie	Szczecin
Poland	Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut	Warszawa
Poland	Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny	Wroclaw
Russian Federation	Hertzen Research Institute of Oncology	Moscow
Russian Federation	N.N Blokchin Cancer Research Centre	Moscow
Russian Federation	Medical Radilogical Research Center of Rams	Obninsk
Spain	Hospital Clinic i Provincial, Sevicio de Oncología Médica	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica	Barcelona
Spain	Hospital Clínico San Carlos, Sevicio de Oncología Médica	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Clinica Universitaria de Navarra, Sevicio de Oncología Médica	Pamplona
Spain	Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica	Santander
Spain	Instituto Valenciano de Oncología: Sevicio de Oncología Médica	Valencia
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	CRUK Institute for Cancer Studies	Birmingham
United Kingdom	Bristol Oncology Centre	Bristol
United Kingdom	Beatson Oncology Center	Glasgow
United Kingdom	Guy's hospital	London
United Kingdom	St George's Healthcare Dept of Oncology, Tooting	London
United Kingdom	St. Bartholomew's Hospital Dept. of Medical Oncology	London
United Kingdom	Northern Centre for Cancer Treatment	Newcastle Upon Tyne
United Kingdom	Lister Hospital Department of Urology	Stevenage Hertfordshire
United Kingdom	Royal Marsden Hospital	Sutton
United States	Texas Cancer Center	Abilene	Texas
United States	Albany Regional Cancer Center	Albany	New York
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Hematology Oncology Associates	Albuquerque	New Mexico
United States	Lovelace Sandia Health Systems	Albuquerque	New Mexico
United States	The University of New Mexico	Albuquerque	New Mexico
United States	Veterans Affairs Medical Center	Albuquerque	New Mexico
United States	Cancer Centers of Florida-Altamonte	Altamonte Springs	Florida
United States	Texas Oncology	Arlington	Texas
United States	Advanced Oncology Associates	Armonk	New York
United States	Southwest Regional Cancer Center	Austin	Texas
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Mamie McFaddin Ward Cancer Center	Beaumont	Texas
United States	Texas Onoclogy PA - Bedford	Bedford	Texas
United States	Birmingham Hematology and Oncology	Birmingham	Alabama
United States	Birmingham Hematology and Oncology	Birmingham	Alabama
United States	The Center for Hematology Oncology	Boca Raton	Florida
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Interlakes Oncology Hematology	Canandaigua	New York
United States	Raleigh Hematology Oncology Clinic	Cary	North Carolina
United States	Oncology Associates of Cedar Rapids	Cedar Rapids	Iowa
United States	Charleston Cancer Center	Charleston	South Carolina
United States	Medical University of South Carolina Hollings Cancer Center	Charleston	South Carolina
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Texas Cancer Center at Medical City	Dallas	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	The Texas Cancer Center	Dallas	Texas
United States	TOPA Sammons Cancer Center	Dallas	Texas
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Texas Cancer Center	Denton	Texas
United States	Rocky Mountain Cancer Center - Midtown	Denver	Colorado
United States	Karmanos Cancer Institute, Wayne State University	Detroit	Michigan
United States	Hematology and Oncology Associates of Northeastern PA / PC	Dunmore	Pennsylvania
United States	Puget Sound Cancer Center - Edmonds	Edmonds	Washington
United States	El Paso Cancer Treatment Center	El Paso	Texas
United States	Willamette Valley Cancer Center	Eugene	Oregon
United States	Central Indiana Cancer Centers	Fishers	Indiana
United States	San Antonio Tumor & Blood Clinic	Fredericksburg	Texas
United States	California Cancer Center	Fresno	California
United States	Texas Oncology, P.A.	Ft. Worth	Texas
United States	Texas Oncology, P.A.	Garland	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	New Hampshire Oncology-Hematology PA	Hooksett	New Hampshire
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Indiana Hematology Oncology Consultants	Indianapolis	Indiana
United States	Texas Oncology, P.A. - Irving	Irving	Texas
United States	Capitol Comprehensive Cancer Care Clinic	Jefferson City	Missouri
United States	Dayton Oncology Hematology	Kettering	Ohio
United States	Louisiana Oncology Associates	Lafayette	Louisiana
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Lake Vista Cancer Center	Lewisville	Texas
United States	Pacific Shores Medical Group	Long Beach	California
United States	Longview Cancer Center	Longview	Texas
United States	Division of Hematology - Oncology	Los Angeles	California
United States	DeQuattro Community Cancer Center	Manchester	Connecticut
United States	Maplewood Cancer Center	Maplewood	Minnesota
United States	S. Texas Cancer Center	McAllen	Texas
United States	The West Clinic	Memphis	Tennessee
United States	Texas Cancer Center of Mesquite	Mesquite	Texas
United States	Hematology/Oncology Group of South Florida	Miami	Florida
United States	Innovative Medical Research of South Florida	Miami Shores	Florida
United States	Allison Cancer Center	Midland	Texas
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	LSU Health Science Center, Stanley S. Scott Cancer Center	New Orleans	Louisiana
United States	Florida Cancer Institute	New Port Richey	Florida
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Northwest Medical Specialists	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	West Texas Cancer Center	Odessa	Texas
United States	Cancer Care Associates	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital Cancer Center	Omaha	Nebraska
United States	Kansas City Cancer Centers - Southwest	Overland Park	Kansas
United States	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Hematology Oncology Associates	Phoenix	Arizona
United States	University of Pittsburgh Cancer Institute- Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Berkshire Hematology Oncology	Pittsfield	Massachusetts
United States	South Florida Oncology & Hematology	Plantation	Florida
United States	Hematology/Oncology Associates of Treasure Coast	Port St. Lucie	Florida
United States	New York Oncology Hematology	Rexford	New York
United States	University of California Davis Cancer Center, Division of Hematology-Oncology	Sacramento	California
United States	Onc and Hem Associates of SW VA, Inc.	Salem	Virginia
United States	Hematology Oncology Associates of South Texas	San Antonio	Texas
United States	Sharp Healthcare - Clinical Oncology Research	San Diego	California
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Maine Center for Cancer Medicine & Blood Disorders	Scarborough	Maine
United States	Northern AZ Hematology & Oncology Assoc.	Sedona	Arizona
United States	Cancer Center of the Carolinas, Seneca	Seneca	South Carolina
United States	North Shore Research Association	Skokie	Illinois
United States	Cancer Care Northwest-North	Spokane	Washington
United States	St. Joseph Oncology, Inc.	St. Joseph	Missouri
United States	Hematology/Oncology Consultants, Inc.	St. Louis	Missouri
United States	VA Medical Center Syracuse	Syracuse	New York
United States	Oncology and Hematology Associates of West Broward P.A.	Tamarac	Florida
United States	Hematology Oncology Physicians/SMO	Tucson	Arizona
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	Arizona Cancer Center	Tuscon	Arizona
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists	Vancouver	Washington
United States	Waco Cancer Care Research Center	Waco	Texas
United States	Arch Medical Services, Inc.	Washington	Missouri
United States	Texas Oncology, P.A. - Deke Slayton Cancer Center	Webster	Texas
United States	Piedmont Hematology - Oncology	Winston - Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Agennix

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Croatia,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Peru,  Poland,  Russian Federation,  Spain,  United Kingdom,