Clinical trial NCT00450970: Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Hormone Refractory Prostate Cancer (HRPC)
Hormone Refractory Prostate Cancer
Unlimited Prior Cytotoxic Chemotherapy Regimens
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2007-03-22
Enrollment: 344
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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

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