Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
- Conditions
- Prostate CancerHormone Refractory Prostate Cancer
- Registration Number
- NCT00069745
- Lead Sponsor
- Agennix
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (204)
University of Pennsylvania Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Texas Cancer Center at Medical City
🇺🇸Dallas, Texas, United States
Marienhospital II
🇩🇪Herne, Germany
Division of Hematology - Oncology
🇺🇸Los Angeles, California, United States
Hematology Oncology Physicians/SMO
🇺🇸Tucson, Arizona, United States
California Cancer Center
🇺🇸Fresno, California, United States
Arizona Cancer Center
🇺🇸Tuscon, Arizona, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Oncology Associates of Cedar Rapids
🇺🇸Cedar Rapids, Iowa, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Kansas City Cancer Centers - Southwest
🇺🇸Overland Park, Kansas, United States
St. Joseph Oncology, Inc.
🇺🇸St. Joseph, Missouri, United States
Advanced Oncology Associates
🇺🇸Armonk, New York, United States
Oncology and Hematology Associates of West Broward P.A.
🇺🇸Tamarac, Florida, United States
Capitol Comprehensive Cancer Care Clinic
🇺🇸Jefferson City, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Arch Medical Services, Inc.
🇺🇸Washington, Missouri, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Fach- und Belegarzte fur Urologie
🇩🇪Berlin, Germany
Albany Regional Cancer Center
🇺🇸Albany, New York, United States
Dayton Oncology Hematology
🇺🇸Kettering, Ohio, United States
CRLC Val d'Aurelle Paul-Lamarque
🇫🇷Montpellier, France
Institut Jean , Service d'Oncologie
🇫🇷Reims, France
CRLC Léon Bérard
🇫🇷Lyon, France
Niedergelassener Urologe
🇩🇪Hamburg, Germany
Institut Bergonié
🇫🇷Bordeaux Cedex, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie
🇫🇷Grenoble Cedex 09, France
RWTH Aachen
🇩🇪Aachen, Germany
Clinique du Mail Service d'Oncologie
🇫🇷Grenoble, France
Stadtische Klinicen Frankfurt a.M. Hochst
🇩🇪Frankfurt a.M. Hochst, Germany
Centre Hospitalier Départemental
🇫🇷La Roche Sur Yon, France
Chu Dupuytren
🇫🇷Limoges, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre Les Nancy, France
Diakonissenkrankenhaus Dessau gGmbH
🇩🇪Dessau, Germany
Universitatklinikum Schleswig-Holstein
🇩🇪Lubeck, Germany
Universitätsklinikum der Carl-Gustav-Carus Universität
🇩🇪Dresden, Germany
Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
🇩🇪Halle, Germany
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
St. Istvan Hospital
🇭🇺Budapest, Hungary
INEN Dept Onco-Hemato
🇵🇪Lima, Peru
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Academic Hospital of the University of Amsterdam
🇳🇱Amsterdam, Netherlands
Akademia Medyczna w Lublinie
🇵🇱Lublin, Poland
Akademia Medyczna w Szczecinie
🇵🇱Szczecin, Poland
Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica
🇪🇸Santander, Spain
N.N Blokchin Cancer Research Centre
🇷🇺Moscow, Russian Federation
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Clinica Universitaria de Navarra, Sevicio de Oncología Médica
🇪🇸Pamplona, Spain
Medical Radilogical Research Center of Rams
🇷🇺Obninsk, Russian Federation
Hospital Clínico San Carlos, Sevicio de Oncología Médica
🇪🇸Madrid, Spain
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Indiana Hematology Oncology Consultants
🇺🇸Indianapolis, Indiana, United States
Sharp Healthcare - Clinical Oncology Research
🇺🇸San Diego, California, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Maplewood Cancer Center
🇺🇸Maplewood, Minnesota, United States
Northern AZ Hematology & Oncology Assoc.
🇺🇸Sedona, Arizona, United States
Maine Center for Cancer Medicine & Blood Disorders
🇺🇸Scarborough, Maine, United States
A.O. San Camillo-Forlanini
🇮🇹Rome, Italy
CHU de Bicêtre
🇫🇷Le Kremlin Bicetre, France
Centre Eugene Marquis
🇫🇷Rennes Cedex, France
Hôpital Tenon
🇫🇷Paris, France
CHU de Poitiers
🇫🇷Poitiers, France
Rocky Mountain Cancer Center - Midtown
🇺🇸Denver, Colorado, United States
Birmingham Hematology and Oncology
🇺🇸Birmingham, Alabama, United States
Karmanos Cancer Institute, Wayne State University
🇺🇸Detroit, Michigan, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
The Center for Hematology Oncology
🇺🇸Boca Raton, Florida, United States
Cancer Centers of Florida-Altamonte
🇺🇸Altamonte Springs, Florida, United States
Innovative Medical Research of South Florida
🇺🇸Miami Shores, Florida, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
Hematology/Oncology Group of South Florida
🇺🇸Miami, Florida, United States
Northwest Medical Specialists
🇺🇸Niles, Illinois, United States
Interlakes Oncology Hematology
🇺🇸Canandaigua, New York, United States
South Florida Oncology & Hematology
🇺🇸Plantation, Florida, United States
DeQuattro Community Cancer Center
🇺🇸Manchester, Connecticut, United States
Hematology/Oncology Associates of Treasure Coast
🇺🇸Port St. Lucie, Florida, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
North Shore Research Association
🇺🇸Skokie, Illinois, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Hematology/Oncology Consultants, Inc.
🇺🇸St. Louis, Missouri, United States
Nebraska Methodist Hospital Cancer Center
🇺🇸Omaha, Nebraska, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
New York Oncology Hematology
🇺🇸Rexford, New York, United States
VA Medical Center Syracuse
🇺🇸Syracuse, New York, United States
Piedmont Hematology - Oncology
🇺🇸Winston - Salem, North Carolina, United States
Raleigh Hematology Oncology Clinic
🇺🇸Cary, North Carolina, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Willamette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
Hematology and Oncology Associates of Northeastern PA / PC
🇺🇸Dunmore, Pennsylvania, United States
University of Pittsburgh Cancer Institute- Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Cancer Center
🇺🇸Denton, Texas, United States
Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Texas Oncology
🇺🇸Arlington, Texas, United States
Texas Oncology, P.A.
🇺🇸Garland, Texas, United States
Texas Onoclogy PA - Bedford
🇺🇸Bedford, Texas, United States
TOPA Sammons Cancer Center
🇺🇸Dallas, Texas, United States
The Texas Cancer Center
🇺🇸Dallas, Texas, United States
S. Texas Cancer Center
🇺🇸McAllen, Texas, United States
San Antonio Tumor & Blood Clinic
🇺🇸Fredericksburg, Texas, United States
El Paso Cancer Treatment Center
🇺🇸El Paso, Texas, United States
Texas Oncology, P.A. - Irving
🇺🇸Irving, Texas, United States
Lake Vista Cancer Center
🇺🇸Lewisville, Texas, United States
Hematology Oncology Associates of South Texas
🇺🇸San Antonio, Texas, United States
Texas Cancer Center of Mesquite
🇺🇸Mesquite, Texas, United States
Longview Cancer Center
🇺🇸Longview, Texas, United States
Allison Cancer Center
🇺🇸Midland, Texas, United States
West Texas Cancer Center
🇺🇸Odessa, Texas, United States
Texas Oncology, P.A. - Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Waco Cancer Care Research Center
🇺🇸Waco, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Onc and Hem Associates of SW VA, Inc.
🇺🇸Salem, Virginia, United States
Puget Sound Cancer Center - Edmonds
🇺🇸Edmonds, Washington, United States
Cancer Care Northwest-North
🇺🇸Spokane, Washington, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
Policlinica Bancaria "9 de Julio" Av. Gaona 2197
🇦🇷Capital Federal, Buenos Aires, Argentina
Centre Hospitalier Belfort-Montbeliard
🇫🇷Montbeliard, France
Centre Antoine Lacassagne Oncologie medicale
🇫🇷Nice Cedex 2, France
Hôpital Saint-Louis: Service de Radiotherapy
🇫🇷Paris, France
Vivantes Krankenhaus am Urban
🇩🇪Berlin, Germany
EuromedClinic
🇩🇪Fürth, Germany
Medizinische Hochschule
🇩🇪Hannover, Germany
Klinickum der Johannes-Gutenberg Universitat
🇩🇪Mainz, Germany
Klinikum der Philipps - Universitat Marburg
🇩🇪Marburg, Germany
Universitatklinikum Munster
🇩🇪Munster, Germany
Klinikum rechts der Isar
🇩🇪München, Germany
Klinik Bad Trissel
🇩🇪Oberaudorf, Germany
Urologische Praxis
🇩🇪Saarbrücken, Germany
St. Margit Hospital
🇭🇺Budapest, Hungary
Pecs Medical University
🇭🇺Pecs, Hungary
National Institute of Oncology
🇭🇺Budapest, Hungary
Soroka Medical Center
🇮🇱Beerhseva, Israel
Universita degli Studi di Napoli Federico II-Nuovo Policlinico
🇮🇹Napoli, Italy
Istituto Nazionale per la Ricerca sul Cancro (IST)
🇮🇹Genoa, Italy
A.S.O. San Luigi
🇮🇹Orbassano, Italy
Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia
🇮🇹Rozanno (MI), Italy
Streekziekenhuis Koningin : Dept. Urology
🇳🇱Winterswijk, Netherlands
Academisch Ziekenhuis Nijmegen: Urology Department
🇳🇱Nijmegen, Netherlands
Essalud Dept. Oncology
🇵🇪Jesus Maria, Peru
Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny
🇵🇱Bialystok, Poland
Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut
🇵🇱Poznan, Poland
Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK
🇵🇱Gdynia, Poland
Akademia Medyczna w Lodzi
🇵🇱Lodz, Poland
Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut
🇵🇱Warszawa, Poland
Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica
🇪🇸Barcelona, Spain
Hospital Clinic i Provincial, Sevicio de Oncología Médica
🇪🇸Barcelona, Spain
Instituto Valenciano de Oncología: Sevicio de Oncología Médica
🇪🇸Valencia, Spain
CRUK Institute for Cancer Studies
🇬🇧Birmingham, United Kingdom
Bristol Oncology Centre
🇬🇧Bristol, United Kingdom
Beatson Oncology Center
🇬🇧Glasgow, United Kingdom
St George's Healthcare Dept of Oncology, Tooting
🇬🇧London, United Kingdom
St. Bartholomew's Hospital Dept. of Medical Oncology
🇬🇧London, United Kingdom
Lister Hospital Department of Urology
🇬🇧Stevenage Hertfordshire, United Kingdom
Northern Centre for Cancer Treatment
🇬🇧Newcastle Upon Tyne, United Kingdom
San Felipe (Oncomedical)
🇵🇪Lima, Peru
Clinica Oncologica de Excelencia
🇦🇷Capital Federal, Buenos Aires, Argentina
Instituto Quirúrgico del Callao
🇦🇷Buenos Aires, Argentina
Instituto Alexander Fleming
🇦🇷Buenos Aires, Argentina
Caici Dept. Oncology
🇦🇷Rosario, Argentina
UCLC St. Luc
🇧🇪Bruxelles, Belgium
Rambam Medical Center
🇮🇱Haifa, Israel
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Hertzen Research Institute of Oncology
🇷🇺Moscow, Russian Federation
Unidad Oncologica del Neuquen
🇦🇷Neuquen, Argentina
Institut Jules Bordet Service de Chimiothérapie
🇧🇪Bruxelles, Belgium
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Berkshire Hematology Oncology
🇺🇸Pittsfield, Massachusetts, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Cancer Center of the Carolinas, Seneca
🇺🇸Seneca, South Carolina, United States
Salisbury Investigaciones Clinicas del Grupo CER S.A.
🇦🇷Quilmes, Buenos Aires, Argentina
Hospital Italiano de Cordoba Dept. Oncology
🇦🇷Cordoba, Argentina
Centro Oncologico Rosario
🇦🇷Rosario, Argentina
Clinical Especializada ISIS
🇦🇷Santa Fe, Argentina
AZ-VUB
🇧🇪Bruxelles, Belgium
Sint Maartenziekenhuis
🇧🇪Kortrijk, Belgium
Clinical Hospital Split Department of Oncology and Radiotherapy
🇭🇷Split, Croatia
Hadassah University
🇮🇱Jerusalem, Israel
Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny
🇵🇱Wroclaw, Poland
New Hampshire Oncology-Hematology PA
🇺🇸Hooksett, New Hampshire, United States
Hospital General de Agudos E. Tornu
🇦🇷Capital Federal, Buenos Aires, Argentina
Hospital Italiano Regional del Sur Dept. Oncology
🇦🇷Bahia Blanca, Argentina
Grupo Plaza Dept. Oncology
🇦🇷Belen de Escobar, Argentina
Centro Oncológico LALCEC
🇦🇷Concepcion del Uruguay, Entre Ríos, Argentina
Centro San Roque
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Hopital Erasme
🇧🇪Bruxelles, Belgium
Clinical Hostpital Rebro Department of Oncology
🇭🇷Zagreb, Croatia
Hospital Ein Kerem Asaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Hospital Italiano de Buenos Aires
🇦🇷Capital Federal, Buenos Aires, Argentina
Hematology Oncology Associates
🇺🇸Albuquerque, New Mexico, United States
University of California Davis Cancer Center, Division of Hematology-Oncology
🇺🇸Sacramento, California, United States
LSU Health Science Center, Stanley S. Scott Cancer Center
🇺🇸New Orleans, Louisiana, United States
Lovelace Sandia Health Systems
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center
🇺🇸Albuquerque, New Mexico, United States
The University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Guy's hospital
🇬🇧London, United Kingdom