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

NCT00450970 | Terminated Phase 3

• 1 other identifier: SAT3-06-04
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 121

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.

Conditions

Prostate Cancer

Keywords

Hormone Refractory Prostate Cancer (HRPC); Hormone Refractory Prostate Cancer; Unlimited Prior Cytotoxic Chemotherapy Regimens

Outcome Measures

Primary Outcomes (1)

• The SPERA trial is designed to provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited prior cytotoxic chemotherapy regimens for metastatic disease.

  Patient evaluation by MD at baseline to determine eligibility.

Study Arms (2)

1

EXPERIMENTAL

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.

Drug: Oral Satraplatin

2

EXPERIMENTAL

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.

Drug: Oral Satraplatin

Interventions

Oral Satraplatin DRUG

The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agennix: lead

Study Sites (121)

Carraway Cancer Clinic

Birmingham, Alabama, 35234, United States

Location

Birmingham Hematology and Oncology

Birmingham, Alabama, 35235, United States

Location

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Clopton Clinic

Jonesboro, Arkansas, 72401, United States

Location

Pacific Cancer Medical Center, Inc

Anaheim, California, 92801, United States

Location

East Valley Hematology Oncology Medical Group

Burbank, California, 91505, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

North Valley Hematology/Oncology Medical Group

Mission Hills, California, 91345, United States

Location

Michael Harris MD

Mission Viejo, California, 92691, United States

Location

Newport Cancer Care Medical Assoc., Inc.

Newport Beach, California, 92663, United States

Location

Medical Oncology Care Associates

Orange, California, 92868, United States

Location

Desert Cancer Center

Rancho Mirage, California, 92270, United States

Location

Sharp Clinical Oncology Research

San Diego, California, 92123, United States

Location

Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

Location

Santa Barbara Hematology Oncology Medical Group

Santa Barbara, California, 93105, United States

Location

Santa Barbara Hemotology

Santa Barbara, California, 93105, United States

Location

Stockton Hematology Oncology Medical Group

Stockton, California, 95204, United States

Location

Sierra Nevada Oncology

Truckee, California, 96161, United States

Location

Rocky Mountain Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

Oncology Associates of Bridgeport

Bridgeport, Connecticut, 06611, United States

Location

Medical Specialists of Fairfield, LLC

Fairfield, Connecticut, 06284, United States

Location

Davis, Posteraro, and Wasser, MDs, LLP

Manchester, Connecticut, 06040, United States

Location

Whittigham Cancer Center at Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Hematology Oncology

Stamford, Connecticut, 06902, United States

Location

Connecticut Oncology & Hematology, LLP

Torrington, Connecticut, 06790, United States

Location

Center for Hematology-Oncology

Boca Raton, Florida, 33486, United States

Location

Florida Cancer Specalists

Bradenton, Florida, 34209, United States

Location

Florida Cancer Care Specialists-Fort Myers Summerlin Office

Fort Myers, Florida, 33908, United States

Location

Gainesville Hematology Oncology Associates

Gainesville, Florida, 32605, United States

Location

ICON

Jacksonville, Florida, 32256, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

MIMA Century Research Assoc.

Melbourne, Florida, 32901, United States

Location

Marc I. Saltzman

Miami, Florida, 33138, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Mid-Florida Hematology & Oncology Centers

Orange City, Florida, 32763, United States

Location

Sacred Heart Hospital Cancer Research

Pensacola, Florida, 32504, United States

Location

Florida Cancer Specialists

Port Charlotte, Florida, 33980, United States

Location

Notheast Georgia Cancer Care, LLC

Athens, Georgia, 30607, United States

Location

Medical Oncology Assoc. of Augusta, PC

Augusta, Georgia, 30901, United States

Location

GA Urology

Decatur, Georgia, 30033, United States

Location

Suburban Hematology-Oncology Assoc., PC

Lawrenceville, Georgia, 30045, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Medical & Surgical Spealists, LLC

Galesburg, Illinois, 61401, United States

Location

Urology Associates, S.C.

Mattoon, Illinois, 61938, United States

Location

Mid-Illinois Hematology and Oncology Assoc., LTD

Normal, Illinois, 61761, United States

Location

Oncology Hematology Associates of Central IL, PC

Peoria, Illinois, 61615, United States

Location

Fort Wayne Medical Oncology Hematology, Inc.

Fort Wayne, Indiana, 46815, United States

Location

Mahendra M. Shah, MD, FACP

Hammond, Indiana, 46320, United States

Location

McFarland Clinic PC

Ames, Iowa, 50010, United States

Location

Iowa Blood and Cancer Care, PLC

Cedar Rapids, Iowa, 52402, United States

Location

Heartland Oncology & Hematology, LLP

Council Bluffs, Iowa, 51503, United States

Location

Cedar Valley Medical Specialists

Waterloo, Iowa, 50702, United States

Location

Drs.Caroll, Sheth and Raghavan

Louisville, Kentucky, 40215, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

The Center for Clinical Research

Hagerstown, Maryland, 21740, United States

Location

Associates in Oncology/Hematology

Rockville, Maryland, 20850, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49546, United States

Location

Kalamazoo Hematology and Oncology

Kalamazoo, Michigan, 49048, United States

Location

Jackson Oncology Associates

Jackson, Mississippi, 39202, United States

Location

NW MS Hem/Onc (Tupelo)

Tupelo, Mississippi, 38801, United States

Location

Columbia Comprehensive Cancer Care Center

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

St. Johns Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

The Center for Cancer Care & Research

St Louis, Missouri, 63141, United States

Location

The Billings Clinic

Billings, Montana, 59101, United States

Location

Saint Francis Memoiral Hospital

Grand Island, Nebraska, 68803, United States

Location

Nebraska Hematology-Oncology,PC

Lincoln, Nebraska, 68506, United States

Location

Cancer Care at St. Claire's

Denville, New Jersey, 07834, United States

Location

Hematology Oncology Associates of Northern New Jersey

Morristown, New Jersey, 07960, United States

Location

Northern Valley Medical

Westwood, New Jersey, 07675, United States

Location

Hematology Oncology Assoc. of W. Suffolk, PC

Bay Shore, New York, 11706, United States

Location

The Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

North Shore Hematology Oncology Assoc.

East Setauket, New York, 11733, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Gaston Hematology and Oncology

Gastonia, North Carolina, 28054, United States

Location

Cancer Center of North Carolina

Raleigh, North Carolina, 27614, United States

Location

MeritCare Clinical Research

Fargo, North Dakota, 58122, United States

Location

Trinity Cancer Care Center

Minot, North Dakota, 58701, United States

Location

Tricounty Hem/Onc Associates

Canton, Ohio, 44718, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Mid-Ohio Oncology/Hematology

Columbus, Ohio, 43219, United States

Location

Hematology-Oncology Consultants, Inc

Columbus, Ohio, 43235, United States

Location

Ohio Cancer Specialists

Mansfield, Ohio, 44907, United States

Location

Cancer Care Associates

Oklahoma City, Oklahoma, 73112, United States

Location

Cancer Specialists of Oklahoma

Oklahoma City, Oklahoma, 73112, United States

Location

Cancer Care Associates

Tulsa, Oklahoma, 73146, United States

Location

Ephrata Cancer Center

Ephrata, Pennsylvania, 17522, United States

Location

Lancaster Cancer Center, Ltd.

Lancaster, Pennsylvania, 17601, United States

Location

Greater Philadelphia Cancer Center

Philadelphia, Pennsylvania, 19114, United States

Location

Carolina Health Care

Florence, South Carolina, 29501, United States

Location

Mid-South Cancer Center, PC

Germantown, Tennessee, 38138, United States

Location

Mid-South Cancer Center

Germantown, Tennessee, 38138, United States

Location

The Jones Clinic

Germantown, Tennessee, 38138, United States

Location

McLeod Cancer and Blood Center

Johnson City, Tennessee, 37604, United States

Location

Kingsport Hematology Oncology

Kingsport, Tennessee, 37660, United States

Location

Boston Baskin Cancer Group D/B/A/ UTCI

Memphis, Tennessee, 38104, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Texas Oncology Cancer Center, PA

Austin, Texas, 78731, United States

Location

Lone Star Oncology Consultants

Austin, Texas, 78759, United States

Location

Coastal Bend Cancer Center

Corpus Christi, Texas, 78463, United States

Location

Mitchell Medical Clinic

Daingerfield, Texas, 75638, United States

Location

Center for Oncology Research and Treatment

Dallas, Texas, 75230, United States

Location

Texas Oncology

Dallas, Texas, 75231, United States

Location

Clinical Oncology & Hematology, LLP

Dallas, Texas, 75235, United States

Location

Dallas Oncology Consultants, PA

Dallas, Texas, 75237, United States

Location

Texas Cancer Center

Denton, Texas, 76210, United States

Location

Cancer Care Centers of South Texas

Fredericksburg, Texas, 78624, United States

Location

Allison Cancer Center

Midland, Texas, 79701, United States

Location

Cancer Care Centers of South Texas

New Braunfels, Texas, 78130, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

Sacred Heart Medical Center - Providence Cancer Care Center

Spokane, Washington, 99204, United States

Location

Northwest Cancer Specialists, PC

Vancouver, Washington, 98684, United States

Location

Green Bay Oncology, Ltd.

Green Bay, Wisconsin, 54301, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

satraplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Philippe Pultar, MD

  GPC Biotech Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: February 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

US (121)