DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: GPC Biotech
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer; Hormone Refractory Prostate Cancer; One Prior Cytotoxic Chemotherapy Regimen

Intervention: Satraplatin (Drug); Prednisone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GPC Biotech

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

Clinical Details

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Hospital Italiano Regional del Sur Dept. Oncology, Bahia Blanca B8001HXM, Argentina

Grupo Plaza Dept. Oncology, Belen de Escobar B1625FWI, Argentina

Caici Dept. Oncology, Rosario S2000DSK, Argentina

Hospital Italiano de Cordoba Dept. Oncology, Cordoba X5004BAL, Argentina

Instituto Quirúrgico del Callao, Buenos Aires C1022AAE, Argentina

Instituto Alexander Fleming, Buenos Aires C1426ANZ, Argentina

Clinical Especializada ISIS, Santa Fe S3000FFU, Argentina

Centro Oncológico LALCEC, Concepcion del Uruguay, Entre Ríos E3260FPB, Argentina

Centro San Roque, San Miguel de Tucumán, Tucumán T4000IAK, Argentina

Unidad Oncologica del Neuquen, Neuquen Q8300HDH, Argentina

Centro Oncologico Rosario, Rosario S2000DSK, Argentina

Institut Jules Bordet Service de Chimiothérapie, Bruxelles B-1000, Belgium

Hopital Erasme, Bruxelles B-1070, Belgium

AZ-VUB, Bruxelles 1090, Belgium

UCLC St. Luc, Bruxelles B-1200, Belgium

Sint Maartenziekenhuis, Kortrijk 8500, Belgium

Clinical Hostpital Rebro Department of Oncology, Zagreb 10000, Croatia

Clinical Hospital Split Department of Oncology and Radiotherapy, Split 21000, Croatia

Hôpital Tenon, Paris 75020, France

CHU de Poitiers, Poitiers 86021, France

Centre Hospitalier Départemental, La Roche Sur Yon 85025, France

CRLC Val d'Aurelle Paul-Lamarque, Montpellier 34298, France

CHU de Bicêtre, Le Kremlin Bicetre 94278, France

Centre Georges François Leclerc, Dijon 21079, France

Institut Bergonié, Bordeaux Cedex 33076, France

CRLC Léon Bérard, Lyon 69373, France

Institut Jean , Service d'Oncologie, Reims 51100, France

Centre Alexis Vautrin, Vandoeuvre Les Nancy 54500, France

Hôpital Saint-Louis: Service de Radiotherapy, Paris 75010, France

Centre Antoine Lacassagne Oncologie medicale, Nice Cedex 2 06189, 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 Eugene Marquis, Rennes Cedex 35042, France

Centre Hospitalier Belfort-Montbeliard, Montbeliard 25209, France

Chu Dupuytren, Limoges 87000, France

Niedergelassener Urologe, Hamburg 22399, Germany

Klinikum rechts der Isar, München 81675, Germany

Klinik Bad Trissel, Oberaudorf 83080, Germany

EuromedClinic, Fürth 90763, Germany

Universitätsklinikum der Carl-Gustav-Carus Universität, Dresden 01307, Germany

Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg, Halle 06120, Germany

Diakonissenkrankenhaus Dessau gGmbH, Dessau 06846, Germany

Fach- und Belegarzte fur Urologie, Berlin 14197, Germany

Medizinische Hochschule, Hannover 30625, Germany

Klinikum der Philipps - Universitat Marburg, Marburg 35043, Germany

RWTH Aachen, Aachen 52074, Germany

Vivantes Krankenhaus am Urban, Berlin 10967, Germany

Stadtische Klinicen Frankfurt a.M. Hochst, Frankfurt a.M. Hochst 65929, Germany

Marienhospital II, Herne 44627, Germany

Klinickum der Johannes-Gutenberg Universitat, Mainz 55131, Germany

Universitatklinikum Munster, Munster 48129, Germany

Universitatklinikum Schleswig-Holstein, Lubeck 23538, Germany

Urologische Praxis, Saarbrücken 04416, Germany

St. Margit Hospital, Budapest 1032, Hungary

National Institute of Oncology, Budapest 1122, Hungary

Pecs Medical University, Pecs 7601, Hungary

St. Istvan Hospital, Budapest 1096, Hungary

Rambam Medical Center, Haifa 31096, Israel

Soroka Medical Center, Beerhseva 84101, Israel

Hadassah University, Jerusalem 91120, Israel

Hospital Ein Kerem Asaf Harofeh Medical Center, Zerifin 70300, Israel

A.O. San Camillo-Forlanini, Rome 00152, Italy

Istituto Nazionale per la Ricerca sul Cancro (IST), Genoa 16132, Italy

A.S.O. San Luigi, Orbassano 10043, Italy

Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia, Rozanno (MI) 20089, Italy

Azienda Ospedaliera di Padova, Padova 35128, Italy

Universita degli Studi di Napoli Federico II-Nuovo Policlinico, Napoli 80131, Italy

Streekziekenhuis Koningin : Dept. Urology, Winterswijk 7101 BN, Netherlands

Academisch Ziekenhuis Nijmegen: Urology Department, Nijmegen GA-6525, Netherlands

Academic Hospital of the University of Amsterdam, Amsterdam 1105 AZ, Netherlands

Essalud Dept. Oncology, Jesus Maria 11, Peru

INEN Dept Onco-Hemato, Lima 34, Peru

San Felipe (Oncomedical), Lima 11, Peru

Akademia Medyczna w Lublinie, Lublin 20-954, Poland

Akademia Medyczna w Lodzi, Lodz 93-509, Poland

Akademia Medyczna w Szczecinie, Szczecin 70-111, Poland

Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny, Bialystok 15-027, Poland

Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny, Wroclaw 50-981, Poland

Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK, Gdynia 81-519, Poland

Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut, Poznan 61-866, Poland

Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut, Warszawa 02-781, Poland

N.N Blokchin Cancer Research Centre, Moscow 115478, Russian Federation

Medical Radilogical Research Center of Rams, Obninsk 249036, Russian Federation

Hertzen Research Institute of Oncology, Moscow 125284, Russian Federation

Instituto Valenciano de Oncología: Sevicio de Oncología Médica, Valencia 46009, 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

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

St. Bartholomew's Hospital Dept. of Medical Oncology, London, United Kingdom

Bristol Oncology Centre, Bristol BS2 8 ED, United Kingdom

Guy's hospital, London SE19RT, United Kingdom

CRUK Institute for Cancer Studies, Birmingham B152TT, United Kingdom

Royal Marsden Hospital, Sutton SM25PT, United Kingdom

Northern Centre for Cancer Treatment, Newcastle Upon Tyne NE4 6BE, United Kingdom

Aberdeen Royal Infirmary, Aberdeen AB25 2ZN, United Kingdom

Lister Hospital Department of Urology, Stevenage Hertfordshire SG1 4 AB, United Kingdom

St George's Healthcare Dept of Oncology, Tooting, London SW17 0QT, United Kingdom

Beatson Oncology Center, Glasgow G11 6NT, United Kingdom

Birmingham Hematology and Oncology, Birmingham, Alabama 35235, United States

Birmingham Hematology and Oncology, Birmingham, Alabama 35205, 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

Clinica Oncologica de Excelencia, Capital Federal, Buenos Aires C1405CBA, Argentina

Salisbury Investigaciones Clinicas del Grupo CER S.A., Quilmes, Buenos Aires B1878DVB, Argentina

Hospital General de Agudos E. Tornu, Capital Federal, Buenos Aires C1427ARN, Argentina

Policlinica Bancaria "9 de Julio" Av. Gaona 2197, Capital Federal, Buenos Aires C1416DRJ, Argentina

Hospital Italiano de Buenos Aires, Capital Federal, Buenos Aires C1181ACH, Argentina

Pacific Shores Medical Group, Long Beach, California 90813, United States

Sharp Healthcare - Clinical Oncology Research, San Diego, California 92123, United States

California Cancer Center, Fresno, California 93720, United States

University of California Davis Cancer Center, Division of Hematology-Oncology, Sacramento, California 95817, United States

Division of Hematology - Oncology, Los Angeles, California 90095-7187, United States

Rocky Mountain Cancer Center - Midtown, Denver, Colorado 80218, United States

DeQuattro Community Cancer Center, Manchester, Connecticut 06040, United States

Hartford Hospital, Hartford, Connecticut 06102, United States

Cancer Centers of Florida-Altamonte, Altamonte Springs, Florida 34761, 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

The Center for Hematology Oncology, Boca Raton, Florida 33486, United States

Hematology/Oncology Group of South Florida, Miami, Florida 33176, United States

Innovative Medical Research of South Florida, Miami Shores, Florida 33179, United States

Northwest Medical Specialists, Niles, Illinois 60714, United States

North Shore Research Association, Skokie, Illinois 60076, United States

Decatur Memorial Hospital, Decatur, Illinois 62526, 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

LSU Health Science Center, Stanley S. Scott Cancer Center, New Orleans, Louisiana 70112, United States

Louisiana Oncology Associates, Lafayette, Louisiana 70506, 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

Hematology/Oncology Consultants, Inc., St. Louis, Missouri 63136, United States

St. Joseph Oncology, Inc., St. Joseph, Missouri 64507, United States

Arch Medical Services, Inc., Washington, Missouri 63090, United States

Missouri Cancer Associates, Columbia, Missouri 65201, United States

Capitol Comprehensive Cancer Care Clinic, Jefferson City, Missouri 65109, United States

Nebraska Methodist Hospital Cancer Center, Omaha, Nebraska 68114, United States

Nevada Cancer Institute, Las Vegas, Nevada 89135, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89109, United States

New Hampshire Oncology-Hematology PA, Hooksett, New Hampshire 03106, United States

Veterans Affairs Medical Center, Albuquerque, New Mexico 87108, United States

Hematology Oncology Associates, Albuquerque, New Mexico 87106, United States

The University of New Mexico, Albuquerque, New Mexico 87131-0001, United States

New Mexico Cancer Care Associates, Santa Fe, New Mexico 87505, United States

Lovelace Sandia Health Systems, Albuquerque, New Mexico 87108, United States

Albany Regional Cancer Center, Albany, New York 12208, United States

Interlakes Oncology Hematology, Canandaigua, New York 14623, 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

New York Oncology Hematology, Rexford, New York 12148, United States

Columbia Presbyterian Medical Center, New York, New York 10032, United States

VA Medical Center Syracuse, Syracuse, New York 13210, United States

Piedmont Hematology - Oncology, Winston - Salem, North Carolina 27103, United States

Raleigh Hematology Oncology Clinic, Cary, North Carolina 27511, 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

Cancer Center of the Carolinas, Seneca, Seneca, South Carolina 29672, United States

Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina 29425, United States

Charleston Cancer Center, Charleston, South Carolina 29406, United States

The West Clinic, Memphis, Tennessee 38120, United States

Allison Cancer Center, Midland, Texas 79701, United States

El Paso Cancer Treatment Center, El Paso, Texas 79915, United States

Hematology Oncology Associates of South Texas, San Antonio, Texas 78229, United States

Lake Vista Cancer Center, Lewisville, Texas 75067, United States

Longview Cancer Center, Longview, Texas 75601, United States

Mamie McFaddin Ward Cancer Center, Beaumont, Texas 77702, United States

Texas Cancer Center at Medical City, Dallas, Texas 75230, United States

Texas Cancer Center of Mesquite, Mesquite, Texas 75150, United States

Texas Cancer Center, Abilene, Texas 79606, United States

Texas Oncology Cancer Center, Austin, Texas 78731, United States

Texas Oncology, P.A. - Irving, Irving, Texas 75601, United States

Texas Oncology, P.A., Garland, Texas 75042, United States

Texas Oncology, P.A., Ft. Worth, Texas 76104, United States

Waco Cancer Care Research Center, Waco, Texas 76712, United States

The Texas Cancer Center, Dallas, Texas 75237, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

S. Texas Cancer Center, McAllen, Texas 78503, United States

West Texas Cancer Center, Odessa, Texas 79761, United States

Southwest Regional Cancer Center, Austin, Texas 78705, United States

San Antonio Tumor & Blood Clinic, Fredericksburg, Texas 78624, United States

Texas Oncology, P.A. - Deke Slayton Cancer Center, Webster, Texas 77598, United States

Texas Oncology, P.A., Dallas, Texas 75231-1449, United States

El Paso Cancer Treatment Center, El Paso, Texas 79915, United States

Texas Oncology, Arlington, Texas 76012, United States

Texas Onoclogy PA - Bedford, Bedford, Texas 76022, United States

Texas Cancer Center, Denton, Texas 76210, United States

TOPA Sammons Cancer Center, Dallas, Texas 75246, United States

Onc and Hem Associates of SW VA, Inc., Salem, Virginia 24153, United States

Virginia Oncology Associates, Norfolk, Virginia 23501, United States

Cancer Care Northwest-North, Spokane, Washington 99218, United States

Northwest Cancer Specialists, Vancouver, Washington 98684, United States

Puget Sound Cancer Center - Edmonds, Edmonds, Washington 98026, United States

Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: September 2003
Ending date: March 2007
Last updated: September 10, 2007

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2009