Spots Global Cancer Trial Database for Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
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Trial Identification
Brief Title: Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
Official Title: Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)
Study ID: NCT00450970
Conditions
Interventions
Study Description
Brief Summary: The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral satraplatin in this patient population.
Detailed Description: \*\*\*\*\*UPDATE\*\*\*\*\* On October 30th, 2007 GPC Biotech announced topline overall survival results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial. The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Carraway Cancer Clinic, Birmingham, Alabama, United States
Birmingham Hematology and Oncology, Birmingham, Alabama, United States
Urology Centers of Alabama, Homewood, Alabama, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Genesis Cancer Center, Hot Springs, Arkansas, United States
Clopton Clinic, Jonesboro, Arkansas, United States
Pacific Cancer Medical Center, Inc, Anaheim, California, United States
East Valley Hematology Oncology Medical Group, Burbank, California, United States
Pacific Shores Medical Group, Long Beach, California, United States
North Valley Hematology/Oncology Medical Group, Mission Hills, California, United States
Michael Harris MD, Mission Viejo, California, United States
Newport Cancer Care Medical Assoc., Inc., Newport Beach, California, United States
Medical Oncology Care Associates, Orange, California, United States
Desert Cancer Center, Rancho Mirage, California, United States
Sharp Clinical Oncology Research, San Diego, California, United States
Pacific Hematology Oncology Associates, San Francisco, California, United States
Santa Barbara Hematology Oncology Medical Group, Santa Barbara, California, United States
Santa Barbara Hemotology, Santa Barbara, California, United States
Stockton Hematology Oncology Medical Group, Stockton, California, United States
Sierra Nevada Oncology, Truckee, California, United States
Rocky Mountain Cancer Center, Colorado Springs, Colorado, United States
Oncology Associates of Bridgeport, Bridgeport, Connecticut, United States
Medical Specialists of Fairfield, LLC, Fairfield, Connecticut, United States
Davis, Posteraro, and Wasser, MDs, LLP, Manchester, Connecticut, United States
Whittigham Cancer Center at Norwalk Hospital, Norwalk, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States
Hematology Oncology, Stamford, Connecticut, United States
Connecticut Oncology & Hematology, LLP, Torrington, Connecticut, United States
Center for Hematology-Oncology, Boca Raton, Florida, United States
Florida Cancer Specalists, Bradenton, Florida, United States
Florida Cancer Care Specialists-Fort Myers Summerlin Office, Fort Myers, Florida, United States
Gainesville Hematology Oncology Associates, Gainesville, Florida, United States
ICON, Jacksonville, Florida, United States
Lakeland Regional Medical Center, Lakeland, Florida, United States
MIMA Century Research Assoc., Melbourne, Florida, United States
Marc I. Saltzman, Miami, Florida, United States
Ocala Oncology Center, Ocala, Florida, United States
Mid-Florida Hematology & Oncology Centers, Orange City, Florida, United States
Sacred Heart Hospital Cancer Research, Pensacola, Florida, United States
Florida Cancer Specialists, Port Charlotte, Florida, United States
Notheast Georgia Cancer Care, LLC, Athens, Georgia, United States
Medical Oncology Assoc. of Augusta, PC, Augusta, Georgia, United States
GA Urology, Decatur, Georgia, United States
Suburban Hematology-Oncology Assoc., PC, Lawrenceville, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Medical & Surgical Spealists, LLC, Galesburg, Illinois, United States
Urology Associates, S.C., Mattoon, Illinois, United States
Mid-Illinois Hematology and Oncology Assoc., LTD, Normal, Illinois, United States
Oncology Hematology Associates of Central IL, PC, Peoria, Illinois, United States
Fort Wayne Medical Oncology Hematology, Inc., Fort Wayne, Indiana, United States
Mahendra M. Shah, MD, FACP, Hammond, Indiana, United States
McFarland Clinic PC, Ames, Iowa, United States
Iowa Blood and Cancer Care, PLC, Cedar Rapids, Iowa, United States
Heartland Oncology & Hematology, LLP, Council Bluffs, Iowa, United States
Cedar Valley Medical Specialists, Waterloo, Iowa, United States
Drs.Caroll, Sheth and Raghavan, Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
The Center for Clinical Research, Hagerstown, Maryland, United States
Associates in Oncology/Hematology, Rockville, Maryland, United States
Lahey Clinic, Burlington, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Kalamazoo Hematology and Oncology, Kalamazoo, Michigan, United States
Jackson Oncology Associates, Jackson, Mississippi, United States
NW MS Hem/Onc (Tupelo), Tupelo, Mississippi, United States
Columbia Comprehensive Cancer Care Center, Columbia, Missouri, United States
Ellis Fischel Cancer Center, Columbia, Missouri, United States
St. Johns Mercy Medical Center, St. Louis, Missouri, United States
The Center for Cancer Care & Research, St. Louis, Missouri, United States
The Billings Clinic, Billings, Montana, United States
Saint Francis Memoiral Hospital, Grand Island, Nebraska, United States
Nebraska Hematology-Oncology,PC, Lincoln, Nebraska, United States
Cancer Care at St. Claire's, Denville, New Jersey, United States
Hematology Oncology Associates of Northern New Jersey, Morristown, New Jersey, United States
Northern Valley Medical, Westwood, New Jersey, United States
Hematology Oncology Assoc. of W. Suffolk, PC, Bay Shore, New York, United States
The Mary Imogene Bassett Hospital, Cooperstown, New York, United States
North Shore Hematology Oncology Assoc., E. Setauket, New York, United States
Richmond University Medical Center, Staten Island, New York, United States
Gaston Hematology and Oncology, Gastonia, North Carolina, United States
Cancer Center of North Carolina, Raleigh, North Carolina, United States
MeritCare Clinical Research, Fargo, North Dakota, United States
Trinity Cancer Care Center, Minot, North Dakota, United States
Tricounty Hem/Onc Associates, Canton, Ohio, United States
The Christ Hospital, Cincinnati, Ohio, United States
Mid-Ohio Oncology/Hematology, Columbus, Ohio, United States
Hematology-Oncology Consultants, Inc, Columbus, Ohio, United States
Ohio Cancer Specialists, Mansfield, Ohio, United States
Cancer Care Associates, Oklahoma City, Oklahoma, United States
Cancer Specialists of Oklahoma, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Ephrata Cancer Center, Ephrata, Pennsylvania, United States
Lancaster Cancer Center, Ltd., Lancaster, Pennsylvania, United States
Greater Philadelphia Cancer Center, Philadelphia, Pennsylvania, United States
Carolina Health Care, Florence, South Carolina, United States
Mid-South Cancer Center, PC, Germantown, Tennessee, United States
Mid-South Cancer Center, Germantown, Tennessee, United States
The Jones Clinic, Germantown, Tennessee, United States
McLeod Cancer and Blood Center, Johnson City, Tennessee, United States
Kingsport Hematology Oncology, Kingsport, Tennessee, United States
Boston Baskin Cancer Group D/B/A/ UTCI, Memphis, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Texas Oncology Cancer Center, PA, Austin, Texas, United States
Lone Star Oncology Consultants, Austin, Texas, United States
Coastal Bend Cancer Center, Corpus Christi, Texas, United States
Mitchell Medical Clinic, Daingerfield, Texas, United States
Center for Oncology Research and Treatment, Dallas, Texas, United States
Texas Oncology, Dallas, Texas, United States
Clinical Oncology & Hematology, LLP, Dallas, Texas, United States
Dallas Oncology Consultants, PA, Dallas, Texas, United States
Texas Cancer Center, Denton, Texas, United States
Cancer Care Centers of South Texas, Fredericksburg, Texas, United States
Allison Cancer Center, Midland, Texas, United States
Cancer Care Centers of South Texas, New Braunfels, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
Peninsula Cancer Institute, Newport News, Virginia, United States
Virginia Oncology Associates, Newport News, Virginia, United States
Sacred Heart Medical Center - Providence Cancer Care Center, Spokane, Washington, United States
Northwest Cancer Specialists, PC, Vancouver, Washington, United States
Green Bay Oncology, Ltd., Green Bay, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Philippe Pultar, MD
Affiliation: GPC Biotech Inc.
Role: STUDY_DIRECTOR
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