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.

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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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

344

Study ID:

NCT00450970

Recruitment Status:

Terminated

Sponsor:

Agennix

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There are 116 Locations for this study

See Locations Near You

Carraway Cancer Clinic
Birmingham Alabama, 35234, United States
Birmingham Hematology and Oncology
Birmingham Alabama, 35235, United States
Urology Centers of Alabama
Homewood Alabama, 35209, United States
Providence Alaska Medical Center
Anchorage Alaska, 99508, United States
Genesis Cancer Center
Hot Springs Arkansas, 71913, United States
Clopton Clinic
Jonesboro Arkansas, 72401, United States
Pacific Cancer Medical Center, Inc
Anaheim California, 92801, United States
East Valley Hematology Oncology Medical Group
Burbank California, 91505, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
North Valley Hematology/Oncology Medical Group
Mission Hills California, 91345, United States
Michael Harris MD
Mission Viejo California, 92691, United States
Newport Cancer Care Medical Assoc., Inc.
Newport Beach California, 92663, United States
Medical Oncology Care Associates
Orange California, 92868, United States
Desert Cancer Center
Rancho Mirage California, 92270, United States
Sharp Clinical Oncology Research
San Diego California, 92123, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
Santa Barbara Hematology Oncology Medical Group
Santa Barbara California, 93105, United States
Santa Barbara Hemotology
Santa Barbara California, 93105, United States
Stockton Hematology Oncology Medical Group
Stockton California, 95204, United States
Sierra Nevada Oncology
Truckee California, 96161, United States
Rocky Mountain Cancer Center
Colorado Springs Colorado, 80909, United States
Oncology Associates of Bridgeport
Bridgeport Connecticut, 06611, United States
Medical Specialists of Fairfield, LLC
Fairfield Connecticut, 06284, United States
Davis, Posteraro, and Wasser, MDs, LLP
Manchester Connecticut, 06040, United States
Whittigham Cancer Center at Norwalk Hospital
Norwalk Connecticut, 06856, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich Connecticut, 06360, United States
Hematology Oncology
Stamford Connecticut, 06902, United States
Connecticut Oncology & Hematology, LLP
Torrington Connecticut, 06790, United States
Center for Hematology-Oncology
Boca Raton Florida, 33486, United States
Florida Cancer Specalists
Bradenton Florida, 34209, United States
Florida Cancer Care Specialists-Fort Myers Summerlin Office
Fort Myers Florida, 33908, United States
Gainesville Hematology Oncology Associates
Gainesville Florida, 32605, United States
ICON
Jacksonville Florida, 32256, United States
Lakeland Regional Medical Center
Lakeland Florida, 33805, United States
MIMA Century Research Assoc.
Melbourne Florida, 32901, United States
Marc I. Saltzman
Miami Florida, 33138, United States
Ocala Oncology Center
Ocala Florida, 34474, United States
Mid-Florida Hematology & Oncology Centers
Orange City Florida, 32763, United States
Sacred Heart Hospital Cancer Research
Pensacola Florida, 32504, United States
Florida Cancer Specialists
Port Charlotte Florida, 33980, United States
Notheast Georgia Cancer Care, LLC
Athens Georgia, 30607, United States
Medical Oncology Assoc. of Augusta, PC
Augusta Georgia, 30901, United States
GA Urology
Decatur Georgia, 30033, United States
Suburban Hematology-Oncology Assoc., PC
Lawrenceville Georgia, 30045, United States
University of Chicago
Chicago Illinois, 60637, United States
Medical & Surgical Spealists, LLC
Galesburg Illinois, 61401, United States
Urology Associates, S.C.
Mattoon Illinois, 61938, United States
Mid-Illinois Hematology and Oncology Assoc., LTD
Normal Illinois, 61761, United States
Oncology Hematology Associates of Central IL, PC
Peoria Illinois, 61615, United States
Fort Wayne Medical Oncology Hematology, Inc.
Fort Wayne Indiana, 46815, United States
Mahendra M. Shah, MD, FACP
Hammond Indiana, 46320, United States
McFarland Clinic PC
Ames Iowa, 50010, United States
Iowa Blood and Cancer Care, PLC
Cedar Rapids Iowa, 52402, United States
Heartland Oncology & Hematology, LLP
Council Bluffs Iowa, 51503, United States
Cedar Valley Medical Specialists
Waterloo Iowa, 50702, United States
Drs.Caroll, Sheth and Raghavan
Louisville Kentucky, 40215, United States
Mary Bird Perkins Cancer Center
Baton Rouge Louisiana, 70809, United States
Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
The Center for Clinical Research
Hagerstown Maryland, 21740, United States
Associates in Oncology/Hematology
Rockville Maryland, 20850, United States
Lahey Clinic
Burlington Massachusetts, 01805, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids Michigan, 49546, United States
Kalamazoo Hematology and Oncology
Kalamazoo Michigan, 49048, United States
Jackson Oncology Associates
Jackson Mississippi, 39202, United States
NW MS Hem/Onc (Tupelo)
Tupelo Mississippi, 38801, United States
Columbia Comprehensive Cancer Care Center
Columbia Missouri, 65201, United States
Ellis Fischel Cancer Center
Columbia Missouri, 65203, United States
St. Johns Mercy Medical Center
St. Louis Missouri, 63141, United States
The Center for Cancer Care & Research
St. Louis Missouri, 63141, United States
The Billings Clinic
Billings Montana, 59101, United States
Saint Francis Memoiral Hospital
Grand Island Nebraska, 68803, United States
Nebraska Hematology-Oncology,PC
Lincoln Nebraska, 68506, United States
Cancer Care at St. Claire's
Denville New Jersey, 07834, United States
Hematology Oncology Associates of Northern New Jersey
Morristown New Jersey, 07960, United States
Northern Valley Medical
Westwood New Jersey, 07675, United States
Hematology Oncology Assoc. of W. Suffolk, PC
Bay Shore New York, 11706, United States
The Mary Imogene Bassett Hospital
Cooperstown New York, 13326, United States
North Shore Hematology Oncology Assoc.
E. Setauket New York, 11733, United States
Richmond University Medical Center
Staten Island New York, 10310, United States
Gaston Hematology and Oncology
Gastonia North Carolina, 28054, United States
Cancer Center of North Carolina
Raleigh North Carolina, 27614, United States
MeritCare Clinical Research
Fargo North Dakota, 58122, United States
Trinity Cancer Care Center
Minot North Dakota, 58701, United States
Tricounty Hem/Onc Associates
Canton Ohio, 44718, United States
The Christ Hospital
Cincinnati Ohio, 45219, United States
Mid-Ohio Oncology/Hematology
Columbus Ohio, 43219, United States
Hematology-Oncology Consultants, Inc
Columbus Ohio, 43235, United States
Ohio Cancer Specialists
Mansfield Ohio, 44907, United States
Cancer Care Associates
Oklahoma City Oklahoma, 73112, United States
Cancer Specialists of Oklahoma
Oklahoma City Oklahoma, 73112, United States
Cancer Care Associates
Tulsa Oklahoma, 73146, United States
Ephrata Cancer Center
Ephrata Pennsylvania, 17522, United States
Lancaster Cancer Center, Ltd.
Lancaster Pennsylvania, 17601, United States
Greater Philadelphia Cancer Center
Philadelphia Pennsylvania, 19114, United States
Carolina Health Care
Florence South Carolina, 29501, United States
Mid-South Cancer Center, PC
Germantown Tennessee, 38138, United States
Mid-South Cancer Center
Germantown Tennessee, 38138, United States
The Jones Clinic
Germantown Tennessee, 38138, United States
McLeod Cancer and Blood Center
Johnson City Tennessee, 37604, United States
Kingsport Hematology Oncology
Kingsport Tennessee, 37660, United States
Boston Baskin Cancer Group D/B/A/ UTCI
Memphis Tennessee, 38104, United States
Harrington Cancer Center
Amarillo Texas, 79106, United States
Texas Oncology Cancer Center, PA
Austin Texas, 78731, United States
Lone Star Oncology Consultants
Austin Texas, 78759, United States
Coastal Bend Cancer Center
Corpus Christi Texas, 78463, United States
Mitchell Medical Clinic
Daingerfield Texas, 75638, United States
Center for Oncology Research and Treatment
Dallas Texas, 75230, United States
Texas Oncology
Dallas Texas, 75231, United States
Clinical Oncology & Hematology, LLP
Dallas Texas, 75235, United States
Dallas Oncology Consultants, PA
Dallas Texas, 75237, United States
Texas Cancer Center
Denton Texas, 76210, United States
Cancer Care Centers of South Texas
Fredericksburg Texas, 78624, United States
Allison Cancer Center
Midland Texas, 79701, United States
Cancer Care Centers of South Texas
New Braunfels Texas, 78130, United States
Northern Utah Associates
Ogden Utah, 84403, United States
Peninsula Cancer Institute
Newport News Virginia, 23601, United States
Virginia Oncology Associates
Newport News Virginia, 23606, United States
Sacred Heart Medical Center - Providence Cancer Care Center
Spokane Washington, 99204, United States
Northwest Cancer Specialists, PC
Vancouver Washington, 98684, United States
Green Bay Oncology, Ltd.
Green Bay Wisconsin, 54301, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

344

Study ID:

NCT00450970

Recruitment Status:

Terminated

Sponsor:


Agennix

How clear is this clinincal trial information?

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