Prostate Cancer Clinical Trial

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

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

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Study ID:

NCT00069745

Recruitment Status:

Completed

Sponsor:

Agennix

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There are 204 Locations for this study

See Locations Near You

Birmingham Hematology and Oncology
Birmingham Alabama, 35205, United States
Birmingham Hematology and Oncology
Birmingham Alabama, 35235, United States
Hematology Oncology Associates
Phoenix Arizona, 85012, United States
Northern AZ Hematology & Oncology Assoc.
Sedona Arizona, 86336, United States
Hematology Oncology Physicians/SMO
Tucson Arizona, 85712, United States
Arizona Cancer Center
Tuscon Arizona, 85724, United States
California Cancer Center
Fresno California, 93720, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
Division of Hematology - Oncology
Los Angeles California, 90095, United States
University of California Davis Cancer Center, Division of Hematology-Oncology
Sacramento California, 95817, United States
Sharp Healthcare - Clinical Oncology Research
San Diego California, 92123, United States
Rocky Mountain Cancer Center - Midtown
Denver Colorado, 80218, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
DeQuattro Community Cancer Center
Manchester Connecticut, 06040, United States
Cancer Centers of Florida-Altamonte
Altamonte Springs Florida, 34761, United States
The Center for Hematology Oncology
Boca Raton Florida, 33486, United States
Innovative Medical Research of South Florida
Miami Shores Florida, 33179, United States
Hematology/Oncology Group of South Florida
Miami Florida, 33176, United States
Florida Cancer Institute
New Port Richey Florida, 34655, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
South Florida Oncology & Hematology
Plantation Florida, 33324, United States
Hematology/Oncology Associates of Treasure Coast
Port St. Lucie Florida, 34952, United States
Oncology and Hematology Associates of West Broward P.A.
Tamarac Florida, 33321, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Northwest Medical Specialists
Niles Illinois, 60714, United States
North Shore Research Association
Skokie Illinois, 60076, United States
Central Indiana Cancer Centers
Fishers Indiana, 46227, United States
Indiana Hematology Oncology Consultants
Indianapolis Indiana, 46202, United States
Central Indiana Cancer Centers
Indianapolis Indiana, 46227, United States
Oncology Associates of Cedar Rapids
Cedar Rapids Iowa, 52403, United States
Kansas City Cancer Centers - Southwest
Overland Park Kansas, 66210, United States
Louisiana Oncology Associates
Lafayette Louisiana, 70506, United States
LSU Health Science Center, Stanley S. Scott Cancer Center
New Orleans Louisiana, 70112, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough Maine, 04074, United States
Berkshire Hematology Oncology
Pittsfield Massachusetts, 01201, United States
Karmanos Cancer Institute, Wayne State University
Detroit Michigan, 48201, United States
Maplewood Cancer Center
Maplewood Minnesota, 55404, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Missouri Cancer Associates
Columbia Missouri, 65201, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City Missouri, 65109, United States
St. Joseph Oncology, Inc.
St. Joseph Missouri, 64507, United States
Hematology/Oncology Consultants, Inc.
St. Louis Missouri, 63136, United States
Arch Medical Services, Inc.
Washington Missouri, 63090, United States
Nebraska Methodist Hospital Cancer Center
Omaha Nebraska, 68114, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89109, United States
Nevada Cancer Institute
Las Vegas Nevada, 89135, United States
New Hampshire Oncology-Hematology PA
Hooksett New Hampshire, 03106, United States
Hematology Oncology Associates
Albuquerque New Mexico, 87106, United States
Lovelace Sandia Health Systems
Albuquerque New Mexico, 87108, United States
Veterans Affairs Medical Center
Albuquerque New Mexico, 87108, United States
The University of New Mexico
Albuquerque New Mexico, 87131, United States
New Mexico Cancer Care Associates
Santa Fe New Mexico, 87505, United States
Albany Regional Cancer Center
Albany New York, 12208, United States
New York Oncology Hematology, P.C.
Albany New York, 12208, United States
Advanced Oncology Associates
Armonk New York, 10504, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Interlakes Oncology Hematology
Canandaigua New York, 14623, United States
Columbia Presbyterian Medical Center
New York New York, 10032, United States
New York Oncology Hematology
Rexford New York, 12148, United States
VA Medical Center Syracuse
Syracuse New York, 13210, United States
Raleigh Hematology Oncology Clinic
Cary North Carolina, 27511, United States
Piedmont Hematology - Oncology
Winston - Salem North Carolina, 27103, United States
Dayton Oncology Hematology
Kettering Ohio, 45067, United States
Cancer Care Associates
Oklahoma City Oklahoma, 73120, United States
Cancer Care Associates
Tulsa Oklahoma, 74136, United States
Willamette Valley Cancer Center
Eugene Oregon, 97401, United States
Hematology and Oncology Associates of Northeastern PA / PC
Dunmore Pennsylvania, 18512, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute- Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Charleston Cancer Center
Charleston South Carolina, 29406, United States
Medical University of South Carolina Hollings Cancer Center
Charleston South Carolina, 29425, United States
Cancer Center of the Carolinas, Seneca
Seneca South Carolina, 29672, United States
The West Clinic
Memphis Tennessee, 38120, United States
Texas Cancer Center
Abilene Texas, 79606, United States
Texas Oncology
Arlington Texas, 76012, United States
Southwest Regional Cancer Center
Austin Texas, 78705, United States
Texas Oncology Cancer Center
Austin Texas, 78731, United States
Mamie McFaddin Ward Cancer Center
Beaumont Texas, 77702, United States
Texas Onoclogy PA - Bedford
Bedford Texas, 76022, United States
Texas Cancer Center at Medical City
Dallas Texas, 75230, United States
Texas Oncology, P.A.
Dallas Texas, 75231, United States
The Texas Cancer Center
Dallas Texas, 75237, United States
TOPA Sammons Cancer Center
Dallas Texas, 75246, United States
Texas Cancer Center
Denton Texas, 76210, United States
El Paso Cancer Treatment Center
El Paso Texas, 79915, United States
San Antonio Tumor & Blood Clinic
Fredericksburg Texas, 78624, United States
Texas Oncology, P.A.
Ft. Worth Texas, 76104, United States
Texas Oncology, P.A.
Garland Texas, 75042, United States
Texas Oncology, P.A. - Irving
Irving Texas, 75601, United States
Lake Vista Cancer Center
Lewisville Texas, 75067, United States
Longview Cancer Center
Longview Texas, 75601, United States
S. Texas Cancer Center
McAllen Texas, 78503, United States
Texas Cancer Center of Mesquite
Mesquite Texas, 75150, United States
Allison Cancer Center
Midland Texas, 79701, United States
West Texas Cancer Center
Odessa Texas, 79761, United States
Hematology Oncology Associates of South Texas
San Antonio Texas, 78229, United States
Tyler Cancer Center
Tyler Texas, 75702, United States
Waco Cancer Care Research Center
Waco Texas, 76712, United States
Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster Texas, 77598, United States
Virginia Oncology Associates
Norfolk Virginia, 23501, United States
Onc and Hem Associates of SW VA, Inc.
Salem Virginia, 24153, United States
Puget Sound Cancer Center - Edmonds
Edmonds Washington, 98026, United States
Cancer Care Northwest-North
Spokane Washington, 99218, United States
Northwest Cancer Specialists
Vancouver Washington, 98684, United States
Froedtert Memorial Lutheran Hospital
Milwaukee Wisconsin, 53226, United States
Hospital Italiano de Buenos Aires
Capital Federal Buenos Aires, C1181, Argentina
Clinica Oncologica de Excelencia
Capital Federal Buenos Aires, C1405, Argentina
Policlinica Bancaria "9 de Julio" Av. Gaona 2197
Capital Federal Buenos Aires, C1416, Argentina
Hospital General de Agudos E. Tornu
Capital Federal Buenos Aires, C1427, Argentina
Salisbury Investigaciones Clinicas del Grupo CER S.A.
Quilmes Buenos Aires, B1878, Argentina
Hospital Italiano Regional del Sur Dept. Oncology
Bahia Blanca , B8001, Argentina
Grupo Plaza Dept. Oncology
Belen de Escobar , B1625, Argentina
Instituto Quirúrgico del Callao
Buenos Aires , C1022, Argentina
Instituto Alexander Fleming
Buenos Aires , C1426, Argentina
Centro Oncológico LALCEC
Concepcion del Uruguay, Entre Ríos , E3260, Argentina
Hospital Italiano de Cordoba Dept. Oncology
Cordoba , X5004, Argentina
Unidad Oncologica del Neuquen
Neuquen , Q8300, Argentina
Caici Dept. Oncology
Rosario , S2000, Argentina
Centro Oncologico Rosario
Rosario , S2000, Argentina
Centro San Roque
San Miguel de Tucumán, Tucumán , T4000, Argentina
Clinical Especializada ISIS
Santa Fe , S3000, Argentina
AZ-VUB
Bruxelles , 1090, Belgium
Institut Jules Bordet Service de Chimiothérapie
Bruxelles , B-100, Belgium
Hopital Erasme
Bruxelles , B-107, Belgium
UCLC St. Luc
Bruxelles , B-120, Belgium
Sint Maartenziekenhuis
Kortrijk , 8500, Belgium
Clinical Hospital Split Department of Oncology and Radiotherapy
Split , 21000, Croatia
Clinical Hostpital Rebro Department of Oncology
Zagreb , 10000, Croatia
Institut Bergonié
Bordeaux Cedex , 33076, France
Centre Georges François Leclerc
Dijon , 21079, France
Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie
Grenoble Cedex 09 , 38043, France
Clinique du Mail Service d'Oncologie
Grenoble , 38100, France
Centre Hospitalier Départemental
La Roche Sur Yon , 85025, France
CHU de Bicêtre
Le Kremlin Bicetre , 94278, France
Chu Dupuytren
Limoges , 87000, France
CRLC Léon Bérard
Lyon , 69373, France
Centre Hospitalier Belfort-Montbeliard
Montbeliard , 25209, France
CRLC Val d'Aurelle Paul-Lamarque
Montpellier , 34298, France
Centre Antoine Lacassagne Oncologie medicale
Nice Cedex 2 , 06189, France
Hôpital Saint-Louis: Service de Radiotherapy
Paris , 75010, France
Hôpital Tenon
Paris , 75020, France
CHU de Poitiers
Poitiers , 86021, France
Institut Jean , Service d'Oncologie
Reims , 51100, France
Centre Eugene Marquis
Rennes Cedex , 35042, France
Centre Alexis Vautrin
Vandoeuvre Les Nancy , 54500, France
RWTH Aachen
Aachen , 52074, Germany
Vivantes Krankenhaus am Urban
Berlin , 10967, Germany
Fach- und Belegarzte fur Urologie
Berlin , 14197, Germany
Diakonissenkrankenhaus Dessau gGmbH
Dessau , 06846, Germany
Universitätsklinikum der Carl-Gustav-Carus Universität
Dresden , 01307, Germany
Stadtische Klinicen Frankfurt a.M. Hochst
Frankfurt a.M. Hochst , 65929, Germany
EuromedClinic
Fürth , 90763, Germany
Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
Halle , 06120, Germany
Niedergelassener Urologe
Hamburg , 22399, Germany
Medizinische Hochschule
Hannover , 30625, Germany
Marienhospital II
Herne , 44627, Germany
Universitatklinikum Schleswig-Holstein
Lubeck , 23538, Germany
Klinickum der Johannes-Gutenberg Universitat
Mainz , 55131, Germany
Klinikum der Philipps - Universitat Marburg
Marburg , 35043, Germany
Universitatklinikum Munster
Munster , 48129, Germany
Klinikum rechts der Isar
München , 81675, Germany
Klinik Bad Trissel
Oberaudorf , 83080, Germany
Urologische Praxis
Saarbrücken , 04416, Germany
St. Margit Hospital
Budapest , 1032, Hungary
St. Istvan Hospital
Budapest , 1096, Hungary
National Institute of Oncology
Budapest , 1122, Hungary
Pecs Medical University
Pecs , 7601, Hungary
Soroka Medical Center
Beerhseva , 84101, Israel
Rambam Medical Center
Haifa , 31096, Israel
Hadassah University
Jerusalem , 91120, Israel
Hospital Ein Kerem Asaf Harofeh Medical Center
Zerifin , 70300, Israel
Istituto Nazionale per la Ricerca sul Cancro (IST)
Genoa , 16132, Italy
Universita degli Studi di Napoli Federico II-Nuovo Policlinico
Napoli , 80131, Italy
A.S.O. San Luigi
Orbassano , 10043, Italy
Azienda Ospedaliera di Padova
Padova , 35128, Italy
A.O. San Camillo-Forlanini
Rome , 00152, Italy
Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia
Rozanno (MI) , 20089, Italy
Academic Hospital of the University of Amsterdam
Amsterdam , 1105 , Netherlands
Academisch Ziekenhuis Nijmegen: Urology Department
Nijmegen , GA-65, Netherlands
Streekziekenhuis Koningin : Dept. Urology
Winterswijk , 7101 , Netherlands
Essalud Dept. Oncology
Jesus Maria , 11, Peru
San Felipe (Oncomedical)
Lima , 11, Peru
INEN Dept Onco-Hemato
Lima , 34, Peru
Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny
Bialystok , 15-02, Poland
Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK
Gdynia , 81-51, Poland
Akademia Medyczna w Lodzi
Lodz , 93-50, Poland
Akademia Medyczna w Lublinie
Lublin , 20-95, Poland
Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut
Poznan , 61-86, Poland
Akademia Medyczna w Szczecinie
Szczecin , 70-11, Poland
Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut
Warszawa , 02-78, Poland
Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny
Wroclaw , 50-98, Poland
N.N Blokchin Cancer Research Centre
Moscow , 11547, Russian Federation
Hertzen Research Institute of Oncology
Moscow , 12528, Russian Federation
Medical Radilogical Research Center of Rams
Obninsk , 24903, Russian Federation
Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica
Barcelona , 08025, Spain
Hospital Clinic i Provincial, Sevicio de Oncología Médica
Barcelona , 08036, Spain
Hospital Ramon y Cajal
Madrid , 20034, Spain
Hospital Clínico San Carlos, Sevicio de Oncología Médica
Madrid , 28040, Spain
Clinica Universitaria de Navarra, Sevicio de Oncología Médica
Pamplona , 31008, Spain
Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica
Santander , 39008, Spain
Instituto Valenciano de Oncología: Sevicio de Oncología Médica
Valencia , 46009, Spain
Aberdeen Royal Infirmary
Aberdeen , AB25 , United Kingdom
CRUK Institute for Cancer Studies
Birmingham , B152T, United Kingdom
Bristol Oncology Centre
Bristol , BS2 8, United Kingdom
Beatson Oncology Center
Glasgow , G11 6, United Kingdom
Guy's hospital
London , SE19R, United Kingdom
St George's Healthcare Dept of Oncology, Tooting
London , SW17 , United Kingdom
St. Bartholomew's Hospital Dept. of Medical Oncology
London , , United Kingdom
Northern Centre for Cancer Treatment
Newcastle Upon Tyne , NE4 6, United Kingdom
Lister Hospital Department of Urology
Stevenage Hertfordshire , SG1 4, United Kingdom
Royal Marsden Hospital
Sutton , SM25P, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Study ID:

NCT00069745

Recruitment Status:

Completed

Sponsor:


Agennix

How clear is this clinincal trial information?

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