Clinical trial NCT00069745: Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Hormone Refractory Prostate Cancer
Keywords: Prostatic Neoplasms
Cancer Treatment Protocols
Antineoplastic protocols
One Prior Cytotoxic Chemotherapy Regimen
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2003-10-06
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: 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


Eligibility criteria: 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

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