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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00069745
First received: September 30, 2003
Last updated: August 1, 2012
Last verified: August 2012
  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
Drug: Satraplatin
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 Agennix:

Study Start Date: September 2003
Study Completion Date: March 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00069745     History of Changes
Other Study ID Numbers: GPC SAT3-03-01
Study First Received: September 30, 2003
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
Prostatic Neoplasms
Cancer Treatment Protocols
Antineoplastic protocols
One Prior Cytotoxic Chemotherapy Regimen

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

ClinicalTrials.gov processed this record on July 23, 2014