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
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
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There are 204 Locations for this study
Birmingham Alabama, 35205, United States
Birmingham Alabama, 35235, United States
Phoenix Arizona, 85012, United States
Sedona Arizona, 86336, United States
Tucson Arizona, 85712, United States
Tuscon Arizona, 85724, United States
Fresno California, 93720, United States
Long Beach California, 90813, United States
Los Angeles California, 90095, United States
Sacramento California, 95817, United States
San Diego California, 92123, United States
Denver Colorado, 80218, United States
Hartford Connecticut, 06102, United States
Manchester Connecticut, 06040, United States
Altamonte Springs Florida, 34761, United States
Boca Raton Florida, 33486, United States
Miami Shores Florida, 33179, United States
Miami Florida, 33176, United States
New Port Richey Florida, 34655, United States
Ocala Florida, 34474, United States
Plantation Florida, 33324, United States
Port St. Lucie Florida, 34952, United States
Tamarac Florida, 33321, United States
Decatur Illinois, 62526, United States
Niles Illinois, 60714, United States
Skokie Illinois, 60076, United States
Fishers Indiana, 46227, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46227, United States
Cedar Rapids Iowa, 52403, United States
Overland Park Kansas, 66210, United States
Lafayette Louisiana, 70506, United States
New Orleans Louisiana, 70112, United States
Scarborough Maine, 04074, United States
Pittsfield Massachusetts, 01201, United States
Detroit Michigan, 48201, United States
Maplewood Minnesota, 55404, United States
Minneapolis Minnesota, 55407, United States
Columbia Missouri, 65201, United States
Jefferson City Missouri, 65109, United States
St. Joseph Missouri, 64507, United States
St. Louis Missouri, 63136, United States
Washington Missouri, 63090, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89109, United States
Las Vegas Nevada, 89135, United States
Hooksett New Hampshire, 03106, United States
Albuquerque New Mexico, 87106, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
Santa Fe New Mexico, 87505, United States
Albany New York, 12208, United States
Albany New York, 12208, United States
Armonk New York, 10504, United States
Buffalo New York, 14263, United States
Canandaigua New York, 14623, United States
New York New York, 10032, United States
Rexford New York, 12148, United States
Syracuse New York, 13210, United States
Cary North Carolina, 27511, United States
Winston - Salem North Carolina, 27103, United States
Kettering Ohio, 45067, United States
Oklahoma City Oklahoma, 73120, United States
Tulsa Oklahoma, 74136, United States
Eugene Oregon, 97401, United States
Dunmore Pennsylvania, 18512, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
Charleston South Carolina, 29406, United States
Charleston South Carolina, 29425, United States
Seneca South Carolina, 29672, United States
Memphis Tennessee, 38120, United States
Abilene Texas, 79606, United States
Arlington Texas, 76012, United States
Austin Texas, 78705, United States
Austin Texas, 78731, United States
Beaumont Texas, 77702, United States
Bedford Texas, 76022, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dallas Texas, 75237, United States
Dallas Texas, 75246, United States
Denton Texas, 76210, United States
El Paso Texas, 79915, United States
Fredericksburg Texas, 78624, United States
Ft. Worth Texas, 76104, United States
Garland Texas, 75042, United States
Irving Texas, 75601, United States
Lewisville Texas, 75067, United States
Longview Texas, 75601, United States
McAllen Texas, 78503, United States
Mesquite Texas, 75150, United States
Midland Texas, 79701, United States
Odessa Texas, 79761, United States
San Antonio Texas, 78229, United States
Tyler Texas, 75702, United States
Waco Texas, 76712, United States
Webster Texas, 77598, United States
Norfolk Virginia, 23501, United States
Salem Virginia, 24153, United States
Edmonds Washington, 98026, United States
Spokane Washington, 99218, United States
Vancouver Washington, 98684, United States
Milwaukee Wisconsin, 53226, United States
Capital Federal Buenos Aires, C1181, Argentina
Capital Federal Buenos Aires, C1405, Argentina
Capital Federal Buenos Aires, C1416, Argentina
Capital Federal Buenos Aires, C1427, Argentina
Quilmes Buenos Aires, B1878, Argentina
Bahia Blanca , B8001, Argentina
Belen de Escobar , B1625, Argentina
Buenos Aires , C1022, Argentina
Buenos Aires , C1426, Argentina
Concepcion del Uruguay, Entre RÃos , E3260, Argentina
Cordoba , X5004, Argentina
Neuquen , Q8300, Argentina
Rosario , S2000, Argentina
Rosario , S2000, Argentina
San Miguel de Tucumán, Tucumán , T4000, Argentina
Santa Fe , S3000, Argentina
Bruxelles , 1090, Belgium
Bruxelles , B-100, Belgium
Bruxelles , B-107, Belgium
Bruxelles , B-120, Belgium
Kortrijk , 8500, Belgium
Split , 21000, Croatia
Zagreb , 10000, Croatia
Bordeaux Cedex , 33076, France
Dijon , 21079, France
Grenoble Cedex 09 , 38043, France
Grenoble , 38100, France
La Roche Sur Yon , 85025, France
Le Kremlin Bicetre , 94278, France
Limoges , 87000, France
Lyon , 69373, France
Montbeliard , 25209, France
Montpellier , 34298, France
Nice Cedex 2 , 06189, France
Paris , 75010, France
Paris , 75020, France
Poitiers , 86021, France
Reims , 51100, France
Rennes Cedex , 35042, France
Vandoeuvre Les Nancy , 54500, France
Aachen , 52074, Germany
Berlin , 10967, Germany
Berlin , 14197, Germany
Dessau , 06846, Germany
Dresden , 01307, Germany
Frankfurt a.M. Hochst , 65929, Germany
Fürth , 90763, Germany
Halle , 06120, Germany
Hamburg , 22399, Germany
Hannover , 30625, Germany
Herne , 44627, Germany
Lubeck , 23538, Germany
Mainz , 55131, Germany
Marburg , 35043, Germany
Munster , 48129, Germany
München , 81675, Germany
Oberaudorf , 83080, Germany
Saarbrücken , 04416, Germany
Budapest , 1032, Hungary
Budapest , 1096, Hungary
Budapest , 1122, Hungary
Pecs , 7601, Hungary
Beerhseva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Zerifin , 70300, Israel
Genoa , 16132, Italy
Napoli , 80131, Italy
Orbassano , 10043, Italy
Padova , 35128, Italy
Rome , 00152, Italy
Rozanno (MI) , 20089, Italy
Amsterdam , 1105 , Netherlands
Nijmegen , GA-65, Netherlands
Winterswijk , 7101 , Netherlands
Jesus Maria , 11, Peru
Lima , 11, Peru
Lima , 34, Peru
Bialystok , 15-02, Poland
Gdynia , 81-51, Poland
Lodz , 93-50, Poland
Lublin , 20-95, Poland
Poznan , 61-86, Poland
Szczecin , 70-11, Poland
Warszawa , 02-78, Poland
Wroclaw , 50-98, Poland
Moscow , 11547, Russian Federation
Moscow , 12528, Russian Federation
Obninsk , 24903, Russian Federation
Barcelona , 08025, Spain
Barcelona , 08036, Spain
Madrid , 20034, Spain
Madrid , 28040, Spain
Pamplona , 31008, Spain
Santander , 39008, Spain
Valencia , 46009, Spain
Aberdeen , AB25 , United Kingdom
Birmingham , B152T, United Kingdom
Bristol , BS2 8, United Kingdom
Glasgow , G11 6, United Kingdom
London , SE19R, United Kingdom
London , SW17 , United Kingdom
London , , United Kingdom
Newcastle Upon Tyne , NE4 6, United Kingdom
Stevenage Hertfordshire , SG1 4, United Kingdom
Sutton , SM25P, United Kingdom
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