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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Hormone Refractory Prostate Cancer
Male
Prostate Cancer, Hormone Refractory Prostate Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
GPC SAT3-03-01
NCT ID:
NCT00069745
Start Date:
September 2003
Completion Date:
March 2007
Related Keywords:
- Prostate Cancer
- Hormone Refractory Prostate Cancer
- Prostatic Neoplasms
- Cancer Treatment Protocols
- Antineoplastic protocols
- One Prior Cytotoxic Chemotherapy Regimen
- Prostatic Neoplasms
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| California Cancer Center | Fresno, California 93720 |
| Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Albany Regional Cancer Center | Albany, New York 12208 |
| Capitol Comprehensive Cancer Care Clinic | Jefferson City, Missouri 65109 |
| Southwest Regional Cancer Center | Austin, Texas 78705 |
| Virginia Oncology Associates | Newport News, Virginia 23606 |
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Ocala Oncology Center | Ocala, Florida 34474 |
| Louisiana Oncology Associates | Lafayette, Louisiana 70506 |
| Missouri Cancer Associates | Columbia, Missouri 65201 |
| Pacific Shores Medical Group | Long Beach, California 90813 |
| Froedtert Memorial Lutheran Hospital | Milwaukee, Wisconsin 53226 |
| New Mexico Cancer Care Associates | Santa Fe, New Mexico 87505-7670 |
| Tyler Cancer Center | Tyler, Texas 75702 |
| Oncology Associates of Cedar Rapids | Cedar Rapids, Iowa 52403 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
| Northwest Cancer Specialists | Vancouver, Washington 98664 |
| Advanced Oncology Associates | Armonk, New York 10504 |
| St. Joseph Oncology, Inc. | Saint Joseph, Missouri 64506 |
| New York Oncology Hematology, P.C. | Albany, New York 12208 |
| New Hampshire Oncology-Hematology PA | Hooksett, New Hampshire 03106 |
| Charleston Cancer Center | Charleston, South Carolina 29406 |
| Innovative Medical Research of South Florida | Miami Shores, Florida 33138 |
| Columbia Presbyterian Medical Center | New York, New York 10032 |
| DeQuattro Community Cancer Center | Manchester, Connecticut 06040 |
| Texas Oncology | Dallas, Texas |
| Raleigh Hematology Oncology Clinic | Cary, North Carolina 27511 |
| Maine Center for Cancer Medicine & Blood Disorders | Scarborough, Maine 04074 |
| Decatur Memorial Hospital | Decatur, Illinois 62526 |
| Northwest Medical Specialists | Arlington Heights, Illinois 60004 |
| Florida Cancer Institute | New Port Richey, Florida 34652 |
| Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
| Texas Cancer Center at Medical City | Dallas, Texas 75230 |
| Allison Cancer Center | Midland, Texas 79701 |
| West Texas Cancer Center | Odessa, Texas 79761 |
| The West Clinic | Memphis, Tennessee 38120 |
| New York Oncology Hematology | Albany, New York 12208 |
| University of Pennsylvania Abramson Cancer Center | Philadelphia, Pennsylvania 19104 |
| Hematology/Oncology Associates of Treasure Coast | Port St. Lucie, Florida 34952 |
| Hematology Oncology Associates | Phoenix, Arizona 85012 |
| Arch Medical Services, INC. | St. Louis, Missouri 63142 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Birmingham Hematology and Oncology | Birmingham, Alabama 35235 |
| Northern AZ Hematology & Oncology Assoc. | Sedona, Arizona 86336 |
| Hematology Oncology Physicians/SMO | Tucson, Arizona 85712 |
| Division of Hematology - Oncology | Los Angeles, California 90095-7187 |
| University of California Davis Cancer Center, Division of Hematology-Oncology | Sacramento, California 95817 |
| Sharp Healthcare - Clinical Oncology Research | San Diego, California 92123 |
| Rocky Mountain Cancer Center - Midtown | Denver, Colorado 80218 |
| Cancer Centers of Florida-Altamonte | Altamonte Springs, Florida 34761 |
| The Center for Hematology Oncology | Boca Raton, Florida 33486 |
| Hematology/Oncology Group of South Florida | Miami, Florida 33176 |
| South Florida Oncology & Hematology | Plantation, Florida 33324 |
| Oncology and Hematology Associates of West Broward P.A. | Tamarac, Florida 33321 |
| North Shore Research Association | Skokie, Illinois 60076 |
| Indiana Hematology Oncology Consultants | Indianapolis, Indiana 46202 |
| Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
| LSU Health Science Center, Stanley S. Scott Cancer Center | New Orleans, Louisiana 70112 |
| Berkshire Hematology Oncology | Pittsfield, Massachusetts 01201 |
| Karmanos Cancer Institute, Wayne State University | Detroit, Michigan 48201 |
| Maplewood Cancer Center | Maplewood, Minnesota 55404 |
| Hematology/Oncology Consultants, Inc. | St. Louis, Missouri 63136 |
| Nebraska Methodist Hospital Cancer Center | Omaha, Nebraska 68114 |
| Veterans Affairs Medical Center | Albuquerque, New Mexico 87108 |
| Hematology Oncology Associates | Albuquerque, New Mexico 87106 |
| The University of New Mexico | Albuquerque, New Mexico 87131-0001 |
| Lovelace Sandia Health Systems | Albuquerque, New Mexico 87108 |
| Interlakes Oncology Hematology | Canandaigua, New York 14623 |
| VA Medical Center Syracuse | Syracuse, New York 13210 |
| Piedmont Hematology - Oncology | Winston - Salem, North Carolina 27103 |
| Dayton Oncology Hematology | Kettering, Ohio 45067 |
| Hematology and Oncology Associates of Northeastern PA / PC | Dunmore, Pennsylvania 18512 |
| University of Pittsburgh Cancer Institute- Hillman Cancer Center | Pittsburgh, Pennsylvania 15232 |
| Medical University of South Carolina Hollings Cancer Center | Charleston, South Carolina 29425 |
| Cancer Center of the Carolinas, Seneca | Seneca, South Carolina 29672 |
| Texas Cancer Center | Abilene, Texas 79606 |
| Texas Oncology Cancer Center | Austin, Texas 78731 |
| Mamie McFaddin Ward Cancer Center | Beaumont, Texas 77702 |
| Texas Onoclogy PA - Bedford | Bedford, Texas 76022 |
| The Texas Cancer Center | Dallas, Texas 75237 |
| TOPA Sammons Cancer Center | Dallas, Texas 75246 |
| El Paso Cancer Treatment Center | El Paso, Texas 79915 |
| San Antonio Tumor & Blood Clinic | Fredericksburg, Texas 78624 |
| Texas Oncology, P.A. - Irving | Irving, Texas 75601 |
| Lake Vista Cancer Center | Lewisville, Texas 75067 |
| Longview Cancer Center | Longview, Texas 75601 |
| S. Texas Cancer Center | McAllen, Texas 78503 |
| Texas Cancer Center of Mesquite | Mesquite, Texas 75150 |
| Hematology Oncology Associates of South Texas | San Antonio, Texas 78229 |
| Waco Cancer Care Research Center | Waco, Texas 76712 |
| Texas Oncology, P.A. - Deke Slayton Cancer Center | Webster, Texas 77598 |
| Onc and Hem Associates of SW VA, Inc. | Salem, Virginia 24153 |
| Puget Sound Cancer Center - Edmonds | Edmonds, Washington 98026 |
| Cancer Care Northwest-North | Spokane, Washington 99218 |
