Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
Sponsor
Agennix (Industry)
Overall Status
Completed
CT.gov ID
NCT00069745
Collaborator
(none)
211
42
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date
:
Sep 1, 2003
Actual Primary Completion Date
:
Jan 1, 2006
Actual Study Completion Date
:
Mar 1, 2007
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham Hematology and Oncology | Birmingham | Alabama | United States | 35205 |
| 2 | Birmingham Hematology and Oncology | Birmingham | Alabama | United States | 35235 |
| 3 | Hematology Oncology Associates | Phoenix | Arizona | United States | 85012 |
| 4 | Northern AZ Hematology & Oncology Assoc. | Sedona | Arizona | United States | 86336 |
| 5 | Hematology Oncology Physicians/SMO | Tucson | Arizona | United States | 85712 |
| 6 | Arizona Cancer Center | Tuscon | Arizona | United States | 85724 |
| 7 | California Cancer Center | Fresno | California | United States | 93720 |
| 8 | Pacific Shores Medical Group | Long Beach | California | United States | 90813 |
| 9 | Division of Hematology - Oncology | Los Angeles | California | United States | 90095-7187 |
| 10 | University of California Davis Cancer Center, Division of Hematology-Oncology | Sacramento | California | United States | 95817 |
| 11 | Sharp Healthcare - Clinical Oncology Research | San Diego | California | United States | 92123 |
| 12 | Rocky Mountain Cancer Center - Midtown | Denver | Colorado | United States | 80218 |
| 13 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 14 | DeQuattro Community Cancer Center | Manchester | Connecticut | United States | 06040 |
| 15 | Cancer Centers of Florida-Altamonte | Altamonte Springs | Florida | United States | 34761 |
| 16 | The Center for Hematology Oncology | Boca Raton | Florida | United States | 33486 |
| 17 | Innovative Medical Research of South Florida | Miami Shores | Florida | United States | 33179 |
| 18 | Hematology/Oncology Group of South Florida | Miami | Florida | United States | 33176 |
| 19 | Florida Cancer Institute | New Port Richey | Florida | United States | 34655 |
| 20 | Ocala Oncology Center | Ocala | Florida | United States | 34474 |
| 21 | South Florida Oncology & Hematology | Plantation | Florida | United States | 33324 |
| 22 | Hematology/Oncology Associates of Treasure Coast | Port St. Lucie | Florida | United States | 34952 |
| 23 | Oncology and Hematology Associates of West Broward P.A. | Tamarac | Florida | United States | 33321 |
| 24 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 25 | Northwest Medical Specialists | Niles | Illinois | United States | 60714 |
| 26 | North Shore Research Association | Skokie | Illinois | United States | 60076 |
| 27 | Central Indiana Cancer Centers | Fishers | Indiana | United States | 46227 |
| 28 | Indiana Hematology Oncology Consultants | Indianapolis | Indiana | United States | 46202 |
| 29 | Central Indiana Cancer Centers | Indianapolis | Indiana | United States | 46227 |
| 30 | Oncology Associates of Cedar Rapids | Cedar Rapids | Iowa | United States | 52403 |
| 31 | Kansas City Cancer Centers - Southwest | Overland Park | Kansas | United States | 66210 |
| 32 | Louisiana Oncology Associates | Lafayette | Louisiana | United States | 70506 |
| 33 | LSU Health Science Center, Stanley S. Scott Cancer Center | New Orleans | Louisiana | United States | 70112 |
| 34 | Maine Center for Cancer Medicine & Blood Disorders | Scarborough | Maine | United States | 04074 |
| 35 | Berkshire Hematology Oncology | Pittsfield | Massachusetts | United States | 01201 |
| 36 | Karmanos Cancer Institute, Wayne State University | Detroit | Michigan | United States | 48201 |
| 37 | Maplewood Cancer Center | Maplewood | Minnesota | United States | 55404 |
| 38 | Virginia Piper Cancer Institute | Minneapolis | Minnesota | United States | 55407 |
| 39 | Missouri Cancer Associates | Columbia | Missouri | United States | 65201 |
| 40 | Capitol Comprehensive Cancer Care Clinic | Jefferson City | Missouri | United States | 65109 |
| 41 | St. Joseph Oncology, Inc. | St. Joseph | Missouri | United States | 64507 |
| 42 | Hematology/Oncology Consultants, Inc. | St. Louis | Missouri | United States | 63136 |
| 43 | Arch Medical Services, Inc. | Washington | Missouri | United States | 63090 |
| 44 | Nebraska Methodist Hospital Cancer Center | Omaha | Nebraska | United States | 68114 |
| 45 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89109 |
| 46 | Nevada Cancer Institute | Las Vegas | Nevada | United States | 89135 |
| 47 | New Hampshire Oncology-Hematology PA | Hooksett | New Hampshire | United States | 03106 |
| 48 | Hematology Oncology Associates | Albuquerque | New Mexico | United States | 87106 |
| 49 | Lovelace Sandia Health Systems | Albuquerque | New Mexico | United States | 87108 |
| 50 | Veterans Affairs Medical Center | Albuquerque | New Mexico | United States | 87108 |
| 51 | The University of New Mexico | Albuquerque | New Mexico | United States | 87131-0001 |
| 52 | New Mexico Cancer Care Associates | Santa Fe | New Mexico | United States | 87505 |
| 53 | Albany Regional Cancer Center | Albany | New York | United States | 12208 |
| 54 | New York Oncology Hematology, P.C. | Albany | New York | United States | 12208 |
| 55 | Advanced Oncology Associates | Armonk | New York | United States | 10504 |
| 56 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 57 | Interlakes Oncology Hematology | Canandaigua | New York | United States | 14623 |
| 58 | Columbia Presbyterian Medical Center | New York | New York | United States | 10032 |
| 59 | New York Oncology Hematology | Rexford | New York | United States | 12148 |
| 60 | VA Medical Center Syracuse | Syracuse | New York | United States | 13210 |
| 61 | Raleigh Hematology Oncology Clinic | Cary | North Carolina | United States | 27511 |
| 62 | Piedmont Hematology - Oncology | Winston - Salem | North Carolina | United States | 27103 |
| 63 | Dayton Oncology Hematology | Kettering | Ohio | United States | 45067 |
| 64 | Cancer Care Associates | Oklahoma City | Oklahoma | United States | 73120 |
| 65 | Cancer Care Associates | Tulsa | Oklahoma | United States | 74136 |
| 66 | Willamette Valley Cancer Center | Eugene | Oregon | United States | 97401 |
| 67 | Hematology and Oncology Associates of Northeastern PA / PC | Dunmore | Pennsylvania | United States | 18512 |
| 68 | University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 69 | University of Pittsburgh Cancer Institute- Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 70 | Charleston Cancer Center | Charleston | South Carolina | United States | 29406 |
| 71 | Medical University of South Carolina Hollings Cancer Center | Charleston | South Carolina | United States | 29425 |
| 72 | Cancer Center of the Carolinas, Seneca | Seneca | South Carolina | United States | 29672 |
| 73 | The West Clinic | Memphis | Tennessee | United States | 38120 |
| 74 | Texas Cancer Center | Abilene | Texas | United States | 79606 |
| 75 | Texas Oncology | Arlington | Texas | United States | 76012 |
| 76 | Southwest Regional Cancer Center | Austin | Texas | United States | 78705 |
| 77 | Texas Oncology Cancer Center | Austin | Texas | United States | 78731 |
| 78 | Mamie McFaddin Ward Cancer Center | Beaumont | Texas | United States | 77702 |
| 79 | Texas Onoclogy PA - Bedford | Bedford | Texas | United States | 76022 |
| 80 | Texas Cancer Center at Medical City | Dallas | Texas | United States | 75230 |
| 81 | Texas Oncology, P.A. | Dallas | Texas | United States | 75231-1449 |
| 82 | The Texas Cancer Center | Dallas | Texas | United States | 75237 |
| 83 | TOPA Sammons Cancer Center | Dallas | Texas | United States | 75246 |
| 84 | Texas Cancer Center | Denton | Texas | United States | 76210 |
| 85 | El Paso Cancer Treatment Center | El Paso | Texas | United States | 79915 |
| 86 | San Antonio Tumor & Blood Clinic | Fredericksburg | Texas | United States | 78624 |
| 87 | Texas Oncology, P.A. | Ft. Worth | Texas | United States | 76104 |
| 88 | Texas Oncology, P.A. | Garland | Texas | United States | 75042 |
| 89 | Texas Oncology, P.A. - Irving | Irving | Texas | United States | 75601 |
| 90 | Lake Vista Cancer Center | Lewisville | Texas | United States | 75067 |
| 91 | Longview Cancer Center | Longview | Texas | United States | 75601 |
| 92 | S. Texas Cancer Center | McAllen | Texas | United States | 78503 |
| 93 | Texas Cancer Center of Mesquite | Mesquite | Texas | United States | 75150 |
| 94 | Allison Cancer Center | Midland | Texas | United States | 79701 |
| 95 | West Texas Cancer Center | Odessa | Texas | United States | 79761 |
| 96 | Hematology Oncology Associates of South Texas | San Antonio | Texas | United States | 78229 |
| 97 | Tyler Cancer Center | Tyler | Texas | United States | 75702 |
| 98 | Waco Cancer Care Research Center | Waco | Texas | United States | 76712 |
| 99 | Texas Oncology, P.A. - Deke Slayton Cancer Center | Webster | Texas | United States | 77598 |
| 100 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23501 |
| 101 | Onc and Hem Associates of SW VA, Inc. | Salem | Virginia | United States | 24153 |
| 102 | Puget Sound Cancer Center - Edmonds | Edmonds | Washington | United States | 98026 |
| 103 | Cancer Care Northwest-North | Spokane | Washington | United States | 99218 |
| 104 | Northwest Cancer Specialists | Vancouver | Washington | United States | 98684 |
| 105 | Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | United States | 53226 |
| 106 | Hospital Italiano de Buenos Aires | Capital Federal | Buenos Aires | Argentina | C1181ACH |
| 107 | Clinica Oncologica de Excelencia | Capital Federal | Buenos Aires | Argentina | C1405CBA |
| 108 | Policlinica Bancaria "9 de Julio" Av. Gaona 2197 | Capital Federal | Buenos Aires | Argentina | C1416DRJ |
| 109 | Hospital General de Agudos E. Tornu | Capital Federal | Buenos Aires | Argentina | C1427ARN |
| 110 | Salisbury Investigaciones Clinicas del Grupo CER S.A. | Quilmes | Buenos Aires | Argentina | B1878DVB |
| 111 | Hospital Italiano Regional del Sur Dept. Oncology | Bahia Blanca | Argentina | B8001HXM | |
| 112 | Grupo Plaza Dept. Oncology | Belen de Escobar | Argentina | B1625FWI | |
| 113 | Instituto Quirúrgico del Callao | Buenos Aires | Argentina | C1022AAE | |
| 114 | Instituto Alexander Fleming | Buenos Aires | Argentina | C1426ANZ | |
| 115 | Centro Oncológico LALCEC | Concepcion del Uruguay, Entre Ríos | Argentina | E3260FPB | |
| 116 | Hospital Italiano de Cordoba Dept. Oncology | Cordoba | Argentina | X5004BAL | |
| 117 | Unidad Oncologica del Neuquen | Neuquen | Argentina | Q8300HDH | |
| 118 | Caici Dept. Oncology | Rosario | Argentina | S2000DSK | |
| 119 | Centro Oncologico Rosario | Rosario | Argentina | S2000DSK | |
| 120 | Centro San Roque | San Miguel de Tucumán, Tucumán | Argentina | T4000IAK | |
| 121 | Clinical Especializada ISIS | Santa Fe | Argentina | S3000FFU | |
| 122 | AZ-VUB | Bruxelles | Belgium | 1090 | |
| 123 | Institut Jules Bordet Service de Chimiothérapie | Bruxelles | Belgium | B-1000 | |
| 124 | Hopital Erasme | Bruxelles | Belgium | B-1070 | |
| 125 | UCLC St. Luc | Bruxelles | Belgium | B-1200 | |
| 126 | Sint Maartenziekenhuis | Kortrijk | Belgium | 8500 | |
| 127 | Clinical Hospital Split Department of Oncology and Radiotherapy | Split | Croatia | 21000 | |
| 128 | Clinical Hostpital Rebro Department of Oncology | Zagreb | Croatia | 10000 | |
| 129 | Institut Bergonié | Bordeaux Cedex | France | 33076 | |
| 130 | Centre Georges François Leclerc | Dijon | France | 21079 | |
| 131 | Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie | Grenoble Cedex 09 | France | 38043 | |
| 132 | Clinique du Mail Service d'Oncologie | Grenoble | France | 38100 | |
| 133 | Centre Hospitalier Départemental | La Roche Sur Yon | France | 85025 | |
| 134 | CHU de Bicêtre | Le Kremlin Bicetre | France | 94278 | |
| 135 | Chu Dupuytren | Limoges | France | 87000 | |
| 136 | CRLC Léon Bérard | Lyon | France | 69373 | |
| 137 | Centre Hospitalier Belfort-Montbeliard | Montbeliard | France | 25209 | |
| 138 | CRLC Val d'Aurelle Paul-Lamarque | Montpellier | France | 34298 | |
| 139 | Centre Antoine Lacassagne Oncologie medicale | Nice Cedex 2 | France | 06189 | |
| 140 | Hôpital Saint-Louis: Service de Radiotherapy | Paris | France | 75010 | |
| 141 | Hôpital Tenon | Paris | France | 75020 | |
| 142 | CHU de Poitiers | Poitiers | France | 86021 | |
| 143 | Institut Jean , Service d'Oncologie | Reims | France | 51100 | |
| 144 | Centre Eugene Marquis | Rennes Cedex | France | 35042 | |
| 145 | Centre Alexis Vautrin | Vandoeuvre Les Nancy | France | 54500 | |
| 146 | RWTH Aachen | Aachen | Germany | 52074 | |
| 147 | Vivantes Krankenhaus am Urban | Berlin | Germany | 10967 | |
| 148 | Fach- und Belegarzte fur Urologie | Berlin | Germany | 14197 | |
| 149 | Diakonissenkrankenhaus Dessau gGmbH | Dessau | Germany | 06846 | |
| 150 | Universitätsklinikum der Carl-Gustav-Carus Universität | Dresden | Germany | 01307 | |
| 151 | Stadtische Klinicen Frankfurt a.M. Hochst | Frankfurt a.M. Hochst | Germany | 65929 | |
| 152 | EuromedClinic | Fürth | Germany | 90763 | |
| 153 | Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg | Halle | Germany | 06120 | |
| 154 | Niedergelassener Urologe | Hamburg | Germany | 22399 | |
| 155 | Medizinische Hochschule | Hannover | Germany | 30625 | |
| 156 | Marienhospital II | Herne | Germany | 44627 | |
| 157 | Universitatklinikum Schleswig-Holstein | Lubeck | Germany | 23538 | |
| 158 | Klinickum der Johannes-Gutenberg Universitat | Mainz | Germany | 55131 | |
| 159 | Klinikum der Philipps - Universitat Marburg | Marburg | Germany | 35043 | |
| 160 | Universitatklinikum Munster | Munster | Germany | 48129 | |
| 161 | Klinikum rechts der Isar | München | Germany | 81675 | |
| 162 | Klinik Bad Trissel | Oberaudorf | Germany | 83080 | |
| 163 | Urologische Praxis | Saarbrücken | Germany | 04416 | |
| 164 | St. Margit Hospital | Budapest | Hungary | 1032 | |
| 165 | St. Istvan Hospital | Budapest | Hungary | 1096 | |
| 166 | National Institute of Oncology | Budapest | Hungary | 1122 | |
| 167 | Pecs Medical University | Pecs | Hungary | 7601 | |
| 168 | Soroka Medical Center | Beerhseva | Israel | 84101 | |
| 169 | Rambam Medical Center | Haifa | Israel | 31096 | |
| 170 | Hadassah University | Jerusalem | Israel | 91120 | |
| 171 | Hospital Ein Kerem Asaf Harofeh Medical Center | Zerifin | Israel | 70300 | |
| 172 | Istituto Nazionale per la Ricerca sul Cancro (IST) | Genoa | Italy | 16132 | |
| 173 | Universita degli Studi di Napoli Federico II-Nuovo Policlinico | Napoli | Italy | 80131 | |
| 174 | A.S.O. San Luigi | Orbassano | Italy | 10043 | |
| 175 | Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
| 176 | A.O. San Camillo-Forlanini | Rome | Italy | 00152 | |
| 177 | Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia | Rozanno (MI) | Italy | 20089 | |
| 178 | Academic Hospital of the University of Amsterdam | Amsterdam | Netherlands | 1105 AZ | |
| 179 | Academisch Ziekenhuis Nijmegen: Urology Department | Nijmegen | Netherlands | GA-6525 | |
| 180 | Streekziekenhuis Koningin : Dept. Urology | Winterswijk | Netherlands | 7101 BN | |
| 181 | Essalud Dept. Oncology | Jesus Maria | Peru | 11 | |
| 182 | San Felipe (Oncomedical) | Lima | Peru | 11 | |
| 183 | INEN Dept Onco-Hemato | Lima | Peru | 34 | |
| 184 | Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny | Bialystok | Poland | 15-027 | |
| 185 | Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK | Gdynia | Poland | 81-519 | |
| 186 | Akademia Medyczna w Lodzi | Lodz | Poland | 93-509 | |
| 187 | Akademia Medyczna w Lublinie | Lublin | Poland | 20-954 | |
| 188 | Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut | Poznan | Poland | 61-866 | |
| 189 | Akademia Medyczna w Szczecinie | Szczecin | Poland | 70-111 | |
| 190 | Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut | Warszawa | Poland | 02-781 | |
| 191 | Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny | Wroclaw | Poland | 50-981 | |
| 192 | N.N Blokchin Cancer Research Centre | Moscow | Russian Federation | 115478 | |
| 193 | Hertzen Research Institute of Oncology | Moscow | Russian Federation | 125284 | |
| 194 | Medical Radilogical Research Center of Rams | Obninsk | Russian Federation | 249036 | |
| 195 | Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica | Barcelona | Spain | 08025 | |
| 196 | Hospital Clinic i Provincial, Sevicio de Oncología Médica | Barcelona | Spain | 08036 | |
| 197 | Hospital Ramon y Cajal | Madrid | Spain | 20034 | |
| 198 | Hospital Clínico San Carlos, Sevicio de Oncología Médica | Madrid | Spain | 28040 | |
| 199 | Clinica Universitaria de Navarra, Sevicio de Oncología Médica | Pamplona | Spain | 31008 | |
| 200 | Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica | Santander | Spain | 39008 | |
| 201 | Instituto Valenciano de Oncología: Sevicio de Oncología Médica | Valencia | Spain | 46009 | |
| 202 | Aberdeen Royal Infirmary | Aberdeen | United Kingdom | AB25 2ZN | |
| 203 | CRUK Institute for Cancer Studies | Birmingham | United Kingdom | B152TT | |
| 204 | Bristol Oncology Centre | Bristol | United Kingdom | BS2 8 ED | |
| 205 | Beatson Oncology Center | Glasgow | United Kingdom | G11 6NT | |
| 206 | Guy's hospital | London | United Kingdom | SE19RT | |
| 207 | St George's Healthcare Dept of Oncology, Tooting | London | United Kingdom | SW17 0QT | |
| 208 | St. Bartholomew's Hospital Dept. of Medical Oncology | London | United Kingdom | ||
| 209 | Northern Centre for Cancer Treatment | Newcastle Upon Tyne | United Kingdom | NE4 6BE | |
| 210 | Lister Hospital Department of Urology | Stevenage Hertfordshire | United Kingdom | SG1 4 AB | |
| 211 | Royal Marsden Hospital | Sutton | United Kingdom | SM25PT |
Sponsors and Collaborators
- Agennix
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Agennix
ClinicalTrials.gov Identifier:
NCT00069745
Other Study ID Numbers:
- GPC SAT3-03-01
First Posted:
Oct 6, 2003
Last Update Posted:
Aug 7, 2012
Last Verified:
Aug 1, 2012
Keywords provided by Agennix
Additional relevant MeSH terms: