Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) (SPERA)
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone Refractory Prostate Cancer (HRPC), Hormone Refractory Prostate Cancer, Unlimited Prior Cytotoxic Chemotherapy Regimens
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
Sites / Locations
- Carraway Cancer Clinic
- Birmingham Hematology and Oncology
- Urology Centers of Alabama
- Providence Alaska Medical Center
- Genesis Cancer Center
- Clopton Clinic
- Pacific Cancer Medical Center, Inc
- East Valley Hematology Oncology Medical Group
- Pacific Shores Medical Group
- North Valley Hematology/Oncology Medical Group
- Michael Harris MD
- Newport Cancer Care Medical Assoc., Inc.
- Medical Oncology Care Associates
- Desert Cancer Center
- Sharp Clinical Oncology Research
- Pacific Hematology Oncology Associates
- Santa Barbara Hematology Oncology Medical Group
- Santa Barbara Hemotology
- Stockton Hematology Oncology Medical Group
- Sierra Nevada Oncology
- Rocky Mountain Cancer Center
- Oncology Associates of Bridgeport
- Medical Specialists of Fairfield, LLC
- Davis, Posteraro, and Wasser, MDs, LLP
- Whittigham Cancer Center at Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Hematology Oncology
- Connecticut Oncology & Hematology, LLP
- Center for Hematology-Oncology
- Florida Cancer Specalists
- Florida Cancer Care Specialists-Fort Myers Summerlin Office
- Gainesville Hematology Oncology Associates
- ICON
- Lakeland Regional Medical Center
- MIMA Century Research Assoc.
- Marc I. Saltzman
- Ocala Oncology Center
- Mid-Florida Hematology & Oncology Centers
- Sacred Heart Hospital Cancer Research
- Florida Cancer Specialists
- Notheast Georgia Cancer Care, LLC
- Medical Oncology Assoc. of Augusta, PC
- GA Urology
- Suburban Hematology-Oncology Assoc., PC
- University of Chicago
- Medical & Surgical Spealists, LLC
- Urology Associates, S.C.
- Mid-Illinois Hematology and Oncology Assoc., LTD
- Oncology Hematology Associates of Central IL, PC
- Fort Wayne Medical Oncology Hematology, Inc.
- Mahendra M. Shah, MD, FACP
- McFarland Clinic PC
- Iowa Blood and Cancer Care, PLC
- Heartland Oncology & Hematology, LLP
- Cedar Valley Medical Specialists
- Drs.Caroll, Sheth and Raghavan
- Mary Bird Perkins Cancer Center
- Center for Cancer and Blood Disorders
- The Center for Clinical Research
- Associates in Oncology/Hematology
- Lahey Clinic
- Cancer & Hematology Centers of Western Michigan
- Kalamazoo Hematology and Oncology
- Jackson Oncology Associates
- NW MS Hem/Onc (Tupelo)
- Columbia Comprehensive Cancer Care Center
- Ellis Fischel Cancer Center
- St. Johns Mercy Medical Center
- The Center for Cancer Care & Research
- The Billings Clinic
- Saint Francis Memoiral Hospital
- Nebraska Hematology-Oncology,PC
- Cancer Care at St. Claire's
- Hematology Oncology Associates of Northern New Jersey
- Northern Valley Medical
- Hematology Oncology Assoc. of W. Suffolk, PC
- The Mary Imogene Bassett Hospital
- North Shore Hematology Oncology Assoc.
- Richmond University Medical Center
- Gaston Hematology and Oncology
- Cancer Center of North Carolina
- MeritCare Clinical Research
- Trinity Cancer Care Center
- Tricounty Hem/Onc Associates
- The Christ Hospital
- Mid-Ohio Oncology/Hematology
- Hematology-Oncology Consultants, Inc
- Ohio Cancer Specialists
- Cancer Care Associates
- Cancer Specialists of Oklahoma
- Cancer Care Associates
- Ephrata Cancer Center
- Lancaster Cancer Center, Ltd.
- Greater Philadelphia Cancer Center
- Carolina Health Care
- Mid-South Cancer Center, PC
- Mid-South Cancer Center
- The Jones Clinic
- McLeod Cancer and Blood Center
- Kingsport Hematology Oncology
- Boston Baskin Cancer Group D/B/A/ UTCI
- Harrington Cancer Center
- Texas Oncology Cancer Center, PA
- Lone Star Oncology Consultants
- Coastal Bend Cancer Center
- Mitchell Medical Clinic
- Center for Oncology Research and Treatment
- Texas Oncology
- Clinical Oncology & Hematology, LLP
- Dallas Oncology Consultants, PA
- Texas Cancer Center
- Cancer Care Centers of South Texas
- Allison Cancer Center
- Cancer Care Centers of South Texas
- Northern Utah Associates
- Peninsula Cancer Institute
- Virginia Oncology Associates
- Sacred Heart Medical Center - Providence Cancer Care Center
- Northwest Cancer Specialists, PC
- Green Bay Oncology, Ltd.
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
Prednisone and Satraplatin (INN / USAN), also known as JM-216, or OC-6-43-bis(acetato-O)ammine dichloro (cyclohexanamine)-platinum (IV), is a member of a novel class of platinum (IV) compounds that are absorbed by the oral route. The lipophilic properties of these compounds, and hence their absorption, are largely determined by the nature of the axial acetate ligands.
Prednisone (17 alpha, 21-dihydroxypregna-1, 4-diene-3, 11, 20-trione) is commercially formulated as the acetate salt (prednisone 21-acetate). It is a biologically inert glucocorticoid, which is converted to active prednisolone in the liver.