Prostate Cancer Clinical Trial
Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
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.
Full 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 Criteria
Inclusion Criteria:
Metastatic(Stage D2)prostate cancer
Progression after unlimited prior cytotoxic chemotherapy regimens
ECOG Performance status equal/less than 2
Surgical or medical castration
Adequate bone marrow, liver, and renal function
Informed consent
Patients treated with bisphosphonates prior to entry are eligible and should continue bisphosphonates therapy while on this trial
Exclusion Criteria:
Serious concurrent uncontrolled medical disorder
Malignant disease requiring on-going therapy
Prior significant RT/radionuclide therapy
Major GI surgery or GI disease affecting absorption
Disease where corticosteroids are contraindicated
Brain metastases
Poorly-controlled or uncontrolled insulin-dependent diabetes
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There are 116 Locations for this study
Birmingham Alabama, 35234, United States
Birmingham Alabama, 35235, United States
Homewood Alabama, 35209, United States
Anchorage Alaska, 99508, United States
Hot Springs Arkansas, 71913, United States
Jonesboro Arkansas, 72401, United States
Anaheim California, 92801, United States
Burbank California, 91505, United States
Long Beach California, 90813, United States
Mission Hills California, 91345, United States
Mission Viejo California, 92691, United States
Newport Beach California, 92663, United States
Orange California, 92868, United States
Rancho Mirage California, 92270, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Santa Barbara California, 93105, United States
Santa Barbara California, 93105, United States
Stockton California, 95204, United States
Truckee California, 96161, United States
Colorado Springs Colorado, 80909, United States
Bridgeport Connecticut, 06611, United States
Fairfield Connecticut, 06284, United States
Manchester Connecticut, 06040, United States
Norwalk Connecticut, 06856, United States
Norwich Connecticut, 06360, United States
Stamford Connecticut, 06902, United States
Torrington Connecticut, 06790, United States
Boca Raton Florida, 33486, United States
Bradenton Florida, 34209, United States
Fort Myers Florida, 33908, United States
Gainesville Florida, 32605, United States
Jacksonville Florida, 32256, United States
Lakeland Florida, 33805, United States
Melbourne Florida, 32901, United States
Miami Florida, 33138, United States
Ocala Florida, 34474, United States
Orange City Florida, 32763, United States
Pensacola Florida, 32504, United States
Port Charlotte Florida, 33980, United States
Athens Georgia, 30607, United States
Augusta Georgia, 30901, United States
Decatur Georgia, 30033, United States
Lawrenceville Georgia, 30045, United States
Chicago Illinois, 60637, United States
Galesburg Illinois, 61401, United States
Mattoon Illinois, 61938, United States
Normal Illinois, 61761, United States
Peoria Illinois, 61615, United States
Fort Wayne Indiana, 46815, United States
Hammond Indiana, 46320, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52402, United States
Council Bluffs Iowa, 51503, United States
Waterloo Iowa, 50702, United States
Louisville Kentucky, 40215, United States
Baton Rouge Louisiana, 70809, United States
Bethesda Maryland, 20817, United States
Hagerstown Maryland, 21740, United States
Rockville Maryland, 20850, United States
Burlington Massachusetts, 01805, United States
Grand Rapids Michigan, 49546, United States
Kalamazoo Michigan, 49048, United States
Jackson Mississippi, 39202, United States
Tupelo Mississippi, 38801, United States
Columbia Missouri, 65201, United States
Columbia Missouri, 65203, United States
St. Louis Missouri, 63141, United States
St. Louis Missouri, 63141, United States
Billings Montana, 59101, United States
Grand Island Nebraska, 68803, United States
Lincoln Nebraska, 68506, United States
Denville New Jersey, 07834, United States
Morristown New Jersey, 07960, United States
Westwood New Jersey, 07675, United States
Bay Shore New York, 11706, United States
Cooperstown New York, 13326, United States
E. Setauket New York, 11733, United States
Staten Island New York, 10310, United States
Gastonia North Carolina, 28054, United States
Raleigh North Carolina, 27614, United States
Fargo North Dakota, 58122, United States
Minot North Dakota, 58701, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43219, United States
Columbus Ohio, 43235, United States
Mansfield Ohio, 44907, United States
Oklahoma City Oklahoma, 73112, United States
Oklahoma City Oklahoma, 73112, United States
Tulsa Oklahoma, 73146, United States
Ephrata Pennsylvania, 17522, United States
Lancaster Pennsylvania, 17601, United States
Philadelphia Pennsylvania, 19114, United States
Florence South Carolina, 29501, United States
Germantown Tennessee, 38138, United States
Germantown Tennessee, 38138, United States
Germantown Tennessee, 38138, United States
Johnson City Tennessee, 37604, United States
Kingsport Tennessee, 37660, United States
Memphis Tennessee, 38104, United States
Amarillo Texas, 79106, United States
Austin Texas, 78731, United States
Austin Texas, 78759, United States
Corpus Christi Texas, 78463, United States
Daingerfield Texas, 75638, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dallas Texas, 75235, United States
Dallas Texas, 75237, United States
Denton Texas, 76210, United States
Fredericksburg Texas, 78624, United States
Midland Texas, 79701, United States
New Braunfels Texas, 78130, United States
Ogden Utah, 84403, United States
Newport News Virginia, 23601, United States
Newport News Virginia, 23606, United States
Spokane Washington, 99204, United States
Vancouver Washington, 98684, United States
Green Bay Wisconsin, 54301, United States
Milwaukee Wisconsin, 53226, United States
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