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

August 1, 2012 updated by: Agennix

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agennix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 30, 2003

First Submitted That Met QC Criteria

October 3, 2003

First Posted (Estimate)

October 6, 2003

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPC SAT3-03-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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