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

Prostate Cancer Clinical Trial

— SPERA  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00450970
• Other study ID #: SAT3-06-04
• Status: Terminated
• Phase: Phase 3
• First received: March 20, 2007
• Last updated: August 9, 2012
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2012
• Source: Agennix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 344
• Est. completion date: December 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Oral Satraplatin
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.

Locations

Country	Name	City	State
United States	Harrington Cancer Center	Amarillo	Texas
United States	McFarland Clinic PC	Ames	Iowa
United States	Pacific Cancer Medical Center, Inc	Anaheim	California
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Notheast Georgia Cancer Care, LLC	Athens	Georgia
United States	Medical Oncology Assoc. of Augusta, PC	Augusta	Georgia
United States	Lone Star Oncology Consultants	Austin	Texas
United States	Texas Oncology Cancer Center, PA	Austin	Texas
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Hematology Oncology Assoc. of W. Suffolk, PC	Bay Shore	New York
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	The Billings Clinic	Billings	Montana
United States	Birmingham Hematology and Oncology	Birmingham	Alabama
United States	Carraway Cancer Clinic	Birmingham	Alabama
United States	Center for Hematology-Oncology	Boca Raton	Florida
United States	Florida Cancer Specalists	Bradenton	Florida
United States	Oncology Associates of Bridgeport	Bridgeport	Connecticut
United States	East Valley Hematology Oncology Medical Group	Burbank	California
United States	Lahey Clinic	Burlington	Massachusetts
United States	Tricounty Hem/Onc Associates	Canton	Ohio
United States	Iowa Blood and Cancer Care, PLC	Cedar Rapids	Iowa
United States	University of Chicago	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Rocky Mountain Cancer Center	Colorado Springs	Colorado
United States	Columbia Comprehensive Cancer Care Center	Columbia	Missouri
United States	Ellis Fischel Cancer Center	Columbia	Missouri
United States	Hematology-Oncology Consultants, Inc	Columbus	Ohio
United States	Mid-Ohio Oncology/Hematology	Columbus	Ohio
United States	The Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Coastal Bend Cancer Center	Corpus Christi	Texas
United States	Heartland Oncology & Hematology, LLP	Council Bluffs	Iowa
United States	Mitchell Medical Clinic	Daingerfield	Texas
United States	Center for Oncology Research and Treatment	Dallas	Texas
United States	Clinical Oncology & Hematology, LLP	Dallas	Texas
United States	Dallas Oncology Consultants, PA	Dallas	Texas
United States	Texas Oncology	Dallas	Texas
United States	GA Urology	Decatur	Georgia
United States	Texas Cancer Center	Denton	Texas
United States	Cancer Care at St. Claire's	Denville	New Jersey
United States	North Shore Hematology Oncology Assoc.	E. Setauket	New York
United States	Ephrata Cancer Center	Ephrata	Pennsylvania
United States	Medical Specialists of Fairfield, LLC	Fairfield	Connecticut
United States	MeritCare Clinical Research	Fargo	North Dakota
United States	Carolina Health Care	Florence	South Carolina
United States	Florida Cancer Care Specialists-Fort Myers Summerlin Office	Fort Myers	Florida
United States	Fort Wayne Medical Oncology Hematology, Inc.	Fort Wayne	Indiana
United States	Cancer Care Centers of South Texas	Fredericksburg	Texas
United States	Gainesville Hematology Oncology Associates	Gainesville	Florida
United States	Medical & Surgical Spealists, LLC	Galesburg	Illinois
United States	Gaston Hematology and Oncology	Gastonia	North Carolina
United States	Mid-South Cancer Center	Germantown	Tennessee
United States	Mid-South Cancer Center, PC	Germantown	Tennessee
United States	The Jones Clinic	Germantown	Tennessee
United States	Saint Francis Memoiral Hospital	Grand Island	Nebraska
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Green Bay Oncology, Ltd.	Green Bay	Wisconsin
United States	The Center for Clinical Research	Hagerstown	Maryland
United States	Mahendra M. Shah, MD, FACP	Hammond	Indiana
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	Jackson Oncology Associates	Jackson	Mississippi
United States	ICON	Jacksonville	Florida
United States	McLeod Cancer and Blood Center	Johnson City	Tennessee
United States	Clopton Clinic	Jonesboro	Arkansas
United States	Kalamazoo Hematology and Oncology	Kalamazoo	Michigan
United States	Kingsport Hematology Oncology	Kingsport	Tennessee
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Lancaster Cancer Center, Ltd.	Lancaster	Pennsylvania
United States	Suburban Hematology-Oncology Assoc., PC	Lawrenceville	Georgia
United States	Nebraska Hematology-Oncology,PC	Lincoln	Nebraska
United States	Pacific Shores Medical Group	Long Beach	California
United States	Drs.Caroll, Sheth and Raghavan	Louisville	Kentucky
United States	Davis, Posteraro, and Wasser, MDs, LLP	Manchester	Connecticut
United States	Ohio Cancer Specialists	Mansfield	Ohio
United States	Urology Associates, S.C.	Mattoon	Illinois
United States	MIMA Century Research Assoc.	Melbourne	Florida
United States	Boston Baskin Cancer Group D/B/A/ UTCI	Memphis	Tennessee
United States	Marc I. Saltzman	Miami	Florida
United States	Allison Cancer Center	Midland	Texas
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Trinity Cancer Care Center	Minot	North Dakota
United States	North Valley Hematology/Oncology Medical Group	Mission Hills	California
United States	Michael Harris MD	Mission Viejo	California
United States	Hematology Oncology Associates of Northern New Jersey	Morristown	New Jersey
United States	Cancer Care Centers of South Texas	New Braunfels	Texas
United States	Newport Cancer Care Medical Assoc., Inc.	Newport Beach	California
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Mid-Illinois Hematology and Oncology Assoc., LTD	Normal	Illinois
United States	Whittigham Cancer Center at Norwalk Hospital	Norwalk	Connecticut
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	Ocala Oncology Center	Ocala	Florida
United States	Northern Utah Associates	Ogden	Utah
United States	Cancer Care Associates	Oklahoma City	Oklahoma
United States	Cancer Specialists of Oklahoma	Oklahoma City	Oklahoma
United States	Medical Oncology Care Associates	Orange	California
United States	Mid-Florida Hematology & Oncology Centers	Orange City	Florida
United States	Sacred Heart Hospital Cancer Research	Pensacola	Florida
United States	Oncology Hematology Associates of Central IL, PC	Peoria	Illinois
United States	Greater Philadelphia Cancer Center	Philadelphia	Pennsylvania
United States	Florida Cancer Specialists	Port Charlotte	Florida
United States	Cancer Center of North Carolina	Raleigh	North Carolina
United States	Desert Cancer Center	Rancho Mirage	California
United States	Associates in Oncology/Hematology	Rockville	Maryland
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	Sacred Heart Medical Center - Providence Cancer Care Center	Spokane	Washington
United States	St. Johns Mercy Medical Center	St. Louis	Missouri
United States	The Center for Cancer Care & Research	St. Louis	Missouri
United States	Hematology Oncology	Stamford	Connecticut
United States	Richmond University Medical Center	Staten Island	New York
United States	Stockton Hematology Oncology Medical Group	Stockton	California
United States	Connecticut Oncology & Hematology, LLP	Torrington	Connecticut
United States	Sierra Nevada Oncology	Truckee	California
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	NW MS Hem/Onc (Tupelo)	Tupelo	Mississippi
United States	Northwest Cancer Specialists, PC	Vancouver	Washington
United States	Cedar Valley Medical Specialists	Waterloo	Iowa
United States	Northern Valley Medical	Westwood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Agennix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes