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Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
This study is ongoing, but not recruiting participants.
First Received: September 30, 2003   Last Updated: September 10, 2007   History of Changes
Sponsor: GPC Biotech
Information provided by: GPC Biotech
ClinicalTrials.gov Identifier: NCT00069745
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Hormone Refractory Prostate Cancer
One Prior Cytotoxic Chemotherapy Regimen
Drug: Satraplatin
Drug: Prednisone
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by GPC Biotech:

Study Start Date: September 2003
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069745

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology
Birmingham, Alabama, United States, 35235
Birmingham Hematology and Oncology
Birmingham, Alabama, United States, 35205
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
Arizona Cancer Center
Tuscon, Arizona, United States, 85724
Hematology Oncology Physicians/SMO
Tucson, Arizona, United States, 85712
Northern AZ Hematology & Oncology Assoc.
Sedona, Arizona, United States, 86336
United States, California
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Sharp Healthcare - Clinical Oncology Research
San Diego, California, United States, 92123
California Cancer Center
Fresno, California, United States, 93720
University of California Davis Cancer Center, Division of Hematology-Oncology
Sacramento, California, United States, 95817
Division of Hematology - Oncology
Los Angeles, California, United States, 90095-7187
United States, Colorado
Rocky Mountain Cancer Center - Midtown
Denver, Colorado, United States, 80218
United States, Connecticut
DeQuattro Community Cancer Center
Manchester, Connecticut, United States, 06040
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Cancer Centers of Florida-Altamonte
Altamonte Springs, Florida, United States, 34761
Florida Cancer Institute
New Port Richey, Florida, United States, 34655
Ocala Oncology Center
Ocala, Florida, United States, 34474
Oncology and Hematology Associates of West Broward P.A.
Tamarac, Florida, United States, 33321
Hematology/Oncology Associates of Treasure Coast
Port St. Lucie, Florida, United States, 34952
South Florida Oncology & Hematology
Plantation, Florida, United States, 33324
The Center for Hematology Oncology
Boca Raton, Florida, United States, 33486
Hematology/Oncology Group of South Florida
Miami, Florida, United States, 33176
Innovative Medical Research of South Florida
Miami Shores, Florida, United States, 33179
United States, Illinois
Northwest Medical Specialists
Niles, Illinois, United States, 60714
North Shore Research Association
Skokie, Illinois, United States, 60076
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
United States, Indiana
Central Indiana Cancer Centers
Fishers, Indiana, United States, 46227
Indiana Hematology Oncology Consultants
Indianapolis, Indiana, United States, 46202
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
United States, Iowa
Oncology Associates of Cedar Rapids
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
United States, Louisiana
LSU Health Science Center, Stanley S. Scott Cancer Center
New Orleans, Louisiana, United States, 70112
Louisiana Oncology Associates
Lafayette, Louisiana, United States, 70506
United States, Maine
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, United States, 04074
United States, Massachusetts
Berkshire Hematology Oncology
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Karmanos Cancer Institute, Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Maplewood Cancer Center
Maplewood, Minnesota, United States, 55404
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Hematology/Oncology Consultants, Inc.
St. Louis, Missouri, United States, 63136
St. Joseph Oncology, Inc.
St. Joseph, Missouri, United States, 64507
Arch Medical Services, Inc.
Washington, Missouri, United States, 63090
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65109
United States, Nebraska
Nebraska Methodist Hospital Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, United States, 03106
United States, New Mexico
Veterans Affairs Medical Center
Albuquerque, New Mexico, United States, 87108
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
The University of New Mexico
Albuquerque, New Mexico, United States, 87131-0001
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
Lovelace Sandia Health Systems
Albuquerque, New Mexico, United States, 87108
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
Interlakes Oncology Hematology
Canandaigua, New York, United States, 14623
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
Advanced Oncology Associates
Armonk, New York, United States, 10504
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
VA Medical Center Syracuse
Syracuse, New York, United States, 13210
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
New York Oncology Hematology
Rexford, New York, United States, 12148
United States, North Carolina
Piedmont Hematology - Oncology
Winston - Salem, North Carolina, United States, 27103
Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States, 27511
United States, Ohio
Dayton Oncology Hematology
Kettering, Ohio, United States, 45067
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73120
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Hematology and Oncology Associates of Northeastern PA / PC
Dunmore, Pennsylvania, United States, 18512
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Cancer Institute- Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Cancer Center of the Carolinas, Seneca
Seneca, South Carolina, United States, 29672
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Allison Cancer Center
Midland, Texas, United States, 79701
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
Hematology Oncology Associates of South Texas
San Antonio, Texas, United States, 78229
Lake Vista Cancer Center
Lewisville, Texas, United States, 75067
Longview Cancer Center
Longview, Texas, United States, 75601
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702
El Paso Cancer Treatment Center
El Paso, Texas, United States, 79915
Texas Cancer Center of Mesquite
Mesquite, Texas, United States, 75150
Texas Cancer Center
Abilene, Texas, United States, 79606
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Texas Oncology, P.A. - Irving
Irving, Texas, United States, 75601
Texas Oncology, P.A.
Garland, Texas, United States, 75042
Texas Oncology, P.A.
Ft. Worth, Texas, United States, 76104
Waco Cancer Care Research Center
Waco, Texas, United States, 76712
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, United States, 78624
Tyler Cancer Center
Tyler, Texas, United States, 75702
S. Texas Cancer Center
McAllen, Texas, United States, 78503
West Texas Cancer Center
Odessa, Texas, United States, 79761
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
The Texas Cancer Center
Dallas, Texas, United States, 75237
Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster, Texas, United States, 77598
Texas Oncology, P.A.
Dallas, Texas, United States, 75231-1449
El Paso Cancer Treatment Center
El Paso, Texas, United States, 79915
Texas Oncology
Arlington, Texas, United States, 76012
TOPA Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Cancer Center
Denton, Texas, United States, 76210
Texas Onoclogy PA - Bedford
Bedford, Texas, United States, 76022
United States, Virginia
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States, 24153
Virginia Oncology Associates
Norfolk, Virginia, United States, 23501
United States, Washington
Cancer Care Northwest-North
Spokane, Washington, United States, 99218
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Puget Sound Cancer Center - Edmonds
Edmonds, Washington, United States, 98026
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Argentina
Hospital Italiano Regional del Sur Dept. Oncology
Bahia Blanca, Argentina, B8001HXM
Grupo Plaza Dept. Oncology
Belen de Escobar, Argentina, B1625FWI
Caici Dept. Oncology
Rosario, Argentina, S2000DSK
Hospital Italiano de Cordoba Dept. Oncology
Cordoba, Argentina, X5004BAL
Clinical Especializada ISIS
Santa Fe, Argentina, S3000FFU
Instituto Alexander Fleming
Buenos Aires, Argentina, C1426ANZ
Instituto Quirúrgico del Callao
Buenos Aires, Argentina, C1022AAE
Centro Oncológico LALCEC
Concepcion del Uruguay, Entre Ríos, Argentina, E3260FPB
Centro San Roque
San Miguel de Tucumán, Tucumán, Argentina, T4000IAK
Unidad Oncologica del Neuquen
Neuquen, Argentina, Q8300HDH
Centro Oncologico Rosario
Rosario, Argentina, S2000DSK
Argentina, Buenos Aires
Hospital General de Agudos E. Tornu
Capital Federal, Buenos Aires, Argentina, C1427ARN
Salisbury Investigaciones Clinicas del Grupo CER S.A.
Quilmes, Buenos Aires, Argentina, B1878DVB
Clinica Oncologica de Excelencia
Capital Federal, Buenos Aires, Argentina, C1405CBA
Policlinica Bancaria "9 de Julio" Av. Gaona 2197
Capital Federal, Buenos Aires, Argentina, C1416DRJ
Hospital Italiano de Buenos Aires
Capital Federal, Buenos Aires, Argentina, C1181ACH
Belgium
Institut Jules Bordet Service de Chimiothérapie
Bruxelles, Belgium, B-1000
Hopital Erasme
Bruxelles, Belgium, B-1070
Sint Maartenziekenhuis
Kortrijk, Belgium, 8500
UCLC St. Luc
Bruxelles, Belgium, B-1200
AZ-VUB
Bruxelles, Belgium, 1090
Croatia
Clinical Hostpital Rebro Department of Oncology
Zagreb, Croatia, 10000
Clinical Hospital Split Department of Oncology and Radiotherapy
Split, Croatia, 21000
France
Hôpital Tenon
Paris, France, 75020
CHU de Poitiers
Poitiers, France, 86021
Centre Hospitalier Départemental
La Roche Sur Yon, France, 85025
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, France, 34298
CHU de Bicêtre
Le Kremlin Bicetre, France, 94278
Centre Georges François Leclerc
Dijon, France, 21079
Institut Bergonié
Bordeaux Cedex, France, 33076
CRLC Léon Bérard
Lyon, France, 69373
Institut Jean , Service d'Oncologie
Reims, France, 51100
Centre Alexis Vautrin
Vandoeuvre Les Nancy, France, 54500
Hôpital Saint-Louis: Service de Radiotherapy
Paris, France, 75010
Chu Dupuytren
Limoges, France, 87000
Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie
Grenoble Cedex 09, France, 38043
Clinique du Mail Service d'Oncologie
Grenoble, France, 38100
Centre Eugene Marquis
Rennes Cedex, France, 35042
Centre Hospitalier Belfort-Montbeliard
Montbeliard, France, 25209
Centre Antoine Lacassagne Oncologie medicale
Nice Cedex 2, France, 06189
Germany
Stadtische Klinicen Frankfurt a.M. Hochst
Frankfurt a.M. Hochst, Germany, 65929
Klinikum rechts der Isar
München, Germany, 81675
Klinik Bad Trissel
Oberaudorf, Germany, 83080
EuromedClinic
Fürth, Germany, 90763
Universitätsklinikum der Carl-Gustav-Carus Universität
Dresden, Germany, 01307
Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
Halle, Germany, 06120
Diakonissenkrankenhaus Dessau gGmbH
Dessau, Germany, 06846
Fach- und Belegarzte fur Urologie
Berlin, Germany, 14197
Medizinische Hochschule
Hannover, Germany, 30625
Klinikum der Philipps - Universitat Marburg
Marburg, Germany, 35043
RWTH Aachen
Aachen, Germany, 52074
Vivantes Krankenhaus am Urban
Berlin, Germany, 10967
Niedergelassener Urologe
Hamburg, Germany, 22399
Marienhospital II
Herne, Germany, 44627
Klinickum der Johannes-Gutenberg Universitat
Mainz, Germany, 55131
Universitatklinikum Munster
Munster, Germany, 48129
Universitatklinikum Schleswig-Holstein
Lubeck, Germany, 23538
Urologische Praxis
Saarbrücken, Germany, 04416
Hungary
St. Margit Hospital
Budapest, Hungary, 1032
National Institute of Oncology
Budapest, Hungary, 1122
Pecs Medical University
Pecs, Hungary, 7601
St. Istvan Hospital
Budapest, Hungary, 1096
Israel
Rambam Medical Center
Haifa, Israel, 31096
Soroka Medical Center
Beerhseva, Israel, 84101
Hadassah University
Jerusalem, Israel, 91120
Hospital Ein Kerem Asaf Harofeh Medical Center
Zerifin, Israel, 70300
Italy
A.O. San Camillo-Forlanini
Rome, Italy, 00152
Istituto Nazionale per la Ricerca sul Cancro (IST)
Genoa, Italy, 16132
A.S.O. San Luigi
Orbassano, Italy, 10043
Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia
Rozanno (MI), Italy, 20089
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Universita degli Studi di Napoli Federico II-Nuovo Policlinico
Napoli, Italy, 80131
Netherlands
Streekziekenhuis Koningin : Dept. Urology
Winterswijk, Netherlands, 7101 BN
Academisch Ziekenhuis Nijmegen: Urology Department
Nijmegen, Netherlands, GA-6525
Academic Hospital of the University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Peru
Essalud Dept. Oncology
Jesus Maria, Peru, 11
INEN Dept Onco-Hemato
Lima, Peru, 34
San Felipe (Oncomedical)
Lima, Peru, 11
Poland
Akademia Medyczna w Lublinie
Lublin, Poland, 20-954
Akademia Medyczna w Lodzi
Lodz, Poland, 93-509
Akademia Medyczna w Szczecinie
Szczecin, Poland, 70-111
Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny
Bialystok, Poland, 15-027
Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny
Wroclaw, Poland, 50-981
Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK
Gdynia, Poland, 81-519
Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut
Poznan, Poland, 61-866
Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut
Warszawa, Poland, 02-781
Russian Federation
N.N Blokchin Cancer Research Centre
Moscow, Russian Federation, 115478
Medical Radilogical Research Center of Rams
Obninsk, Russian Federation, 249036
Hertzen Research Institute of Oncology
Moscow, Russian Federation, 125284
Spain
Instituto Valenciano de Oncología: Sevicio de Oncología Médica
Valencia, Spain, 46009
Hospital Clínico San Carlos, Sevicio de Oncología Médica
Madrid, Spain, 28040
Clinica Universitaria de Navarra, Sevicio de Oncología Médica
Pamplona, Spain, 31008
Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica
Santander, Spain, 39008
Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica
Barcelona, Spain, 08025
Hospital Clinic i Provincial, Sevicio de Oncología Médica
Barcelona, Spain, 08036
Hospital Ramon y Cajal
Madrid, Spain, 20034
United Kingdom
St. Bartholomew's Hospital Dept. of Medical Oncology
London, United Kingdom
Bristol Oncology Centre
Bristol, United Kingdom, BS2 8 ED
Guy's hospital
London, United Kingdom, SE19RT
CRUK Institute for Cancer Studies
Birmingham, United Kingdom, B152TT
Beatson Oncology Center
Glasgow, United Kingdom, G11 6NT
Northern Centre for Cancer Treatment
Newcastle Upon Tyne, United Kingdom, NE4 6BE
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Lister Hospital Department of Urology
Stevenage Hertfordshire, United Kingdom, SG1 4 AB
St George's Healthcare Dept of Oncology, Tooting
London, United Kingdom, SW17 0QT
Royal Marsden Hospital
Sutton, United Kingdom, SM25PT
Sponsors and Collaborators
GPC Biotech
  More Information

No publications provided

Study ID Numbers: GPC SAT3-03-01
Study First Received: September 30, 2003
Last Updated: September 10, 2007
ClinicalTrials.gov Identifier: NCT00069745     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GPC Biotech:
Prostatic Neoplasms
Cancer Treatment Protocols
Antineoplastic protocols

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Satraplatin
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009