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Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)


*****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.


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

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

Patient evaluation by MD at baseline to determine eligibility.

Safety Issue:

Yes

Principal Investigator

Philippe Pultar, MD

Investigator Role:

Study Director

Investigator Affiliation:

GPC Biotech Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SAT3-06-04

NCT ID:

NCT00450970

Start Date:

February 2007

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • Hormone Refractory Prostate Cancer (HRPC)
  • Hormone Refractory Prostate Cancer
  • Unlimited Prior Cytotoxic Chemotherapy Regimens
  • Prostatic Neoplasms

Name

Location

Medical College of Wisconsin Milwaukee, Wisconsin  53226
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Harrington Cancer Center Amarillo, Texas  79106
Providence Alaska Medical Center Anchorage, Alaska  99508
Virginia Oncology Associates Newport News, Virginia  23606
Trinity Cancer Care Center Minot, North Dakota  58701
Rocky Mountain Cancer Center Denver, Colorado  80218
Ocala Oncology Center Ocala, Florida  34474
Green Bay Oncology, Ltd. Green Bay, Wisconsin  54307-3453
Florida Cancer Specialists Fort Myers, Florida  33901
Ellis Fischel Cancer Center Columbia, Missouri  65203
Eastern Connecticut Hematology and Oncology Associates Norwich, Connecticut  06360
Pacific Shores Medical Group Long Beach, California  90813
Lakeland Regional Medical Center Lakeland, Florida  33804
Gaston Hematology and Oncology Gastonia, North Carolina  28054
Genesis Cancer Center Hot Springs, Arkansas  71913
Center for Hematology-Oncology Boca Raton, Florida  33486
Medical Oncology Care Associates Orange, California  92668
Cancer Care Associates Tulsa, Oklahoma  74136
Associates in Oncology/Hematology Rockville, Maryland  20850
Center for Oncology Research and Treatment Dallas, Texas  75230
Northern Utah Associates Ogden, Utah  84403
Stockton Hematology Oncology Medical Group Stockton, California  95204
Lahey Clinic Burlington, Massachusetts  01805
University of Chicago Chicago, Illinois  60637
Urology Centers Of Alabama Homewood,, Alabama  35205
Texas Oncology Dallas, Texas  
Pacific Hematology Oncology Associates San Francisco, California  94115
Santa Barbara Hematology Oncology Medical Group Lompoc, California  93438
North Valley Hematology/Oncology Medical Group Northridge, California  91328
Cancer & Hematology Centers of Western Michigan Grand Rapids, Michigan  49546
Allison Cancer Center Midland, Texas  79701
Peninsula Cancer Institute Newport News, Virginia  23601
Sharp Clinical Oncology Research San Diego, California  92123
Hematology Oncology Associates of Northern New Jersey Morristown, New Jersey  07960
The Jones Clinic Germantown, Tennessee  38138
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
The Mary Imogene Bassett Hospital Cooperstown, New York  13326
St. Johns Mercy Medical Center St. Louis, Missouri  63141
Birmingham Hematology and Oncology Birmingham, Alabama  35235
Texas Cancer Center Abilene, Texas  79606
Ephrata Cancer Center Ephrata, Pennsylvania  17522
East Valley Hematology Oncology Medical Group Burbank, California  91505
Dallas Oncology Consultants, PA Dallas, Texas  75237
The Center for Cancer Care & Research St. Louis, Missouri  63141
Northwest Cancer Specialists, PC Vancouver, Washington  98684
Cedar Valley Medical Specialists Waterloo, Iowa  50702
Cancer Specialists of Oklahoma Oklahoma City, Oklahoma  73112
Oncology Associates of Bridgeport Trumball, Connecticut  06611
Kalamazoo Hematology and Oncology Kalamazoo, Michigan  49048
Gainesville Hematology Oncology Associates Gainesville, Florida  32605
Coastal Bend Cancer Center Corpus Christi, Texas  78404
McLeod Cancer and Blood Center Johnson City, Tennessee  37604
Cancer Care Centers of South Texas San Antonio, Texas  78229
Jackson Oncology Associates Jackson, Mississippi  39202
Connecticut Oncology & Hematology, LLP Torrington, Connecticut  06790
Ohio Cancer Specialists Mansfield, Ohio  44907
Lone Star Oncology Consultants Austin, Texas  78759
Richmond University Medical Center Staten Island, New York  10310-1699
Pacific Cancer Medical Center, Inc Anaheim, California  92801
Lancaster Cancer Center, Ltd. Lancaster, Pennsylvania  17601
The Christ Hospital Cincinnati, Ohio  45219
Mid-Ohio Oncology/Hematology Columbus, Ohio  43219
Mcfarland Clinic Pc Ames, Iowa  50010
Carraway Cancer Clinic Birmingham, Alabama  35234
Clopton Clinic Jonesboro, Arkansas  72401
Michael Harris MD Mission Viejo, California  92691
Newport Cancer Care Medical Assoc., Inc. Newport Beach, California  92663
Desert Cancer Center Rancho Mirage, California  92270
Santa Barbara Hemotology Santa Barbara, California  93105
Sierra Nevada Oncology Truckee, California  96161
Medical Specialists of Fairfield, LLC Fairfield, Connecticut  06284
Davis, Posteraro, and Wasser, MDs, LLP Manchester, Connecticut  06040
Whittigham Cancer Center at Norwalk Hospital Norwalk, Connecticut  06856
Hematology Oncology Stamford, Connecticut  06902
Florida Cancer Specalists Bradenton, Florida  34209
Florida Cancer Care Specialists-Fort Myers Summerlin Office Fort Myers, Florida  33908
ICON Jacksonville, Florida  32256
MIMA Century Research Assoc. Melbourne, Florida  32901
Marc I. Saltzman Miami, Florida  33138
Mid-Florida Hematology & Oncology Centers Orange City, Florida  32763
Sacred Heart Hospital Cancer Research Pensacola, Florida  32504
Notheast Georgia Cancer Care, LLC Athens, Georgia  30607
Medical Oncology Assoc. of Augusta, PC Augusta, Georgia  30901
GA Urology Decatur, Georgia  30033
Suburban Hematology-Oncology Assoc., PC Lawrenceville, Georgia  30045
Medical & Surgical Spealists, LLC Galesburg, Illinois  61401
Urology Associates, S.C. Mattoon, Illinois  61938
Mid-Illinois Hematology and Oncology Assoc., LTD Normal, Illinois  61761
Oncology Hematology Associates of Central IL, PC Peoria, Illinois  61615
Fort Wayne Medical Oncology Hematology, Inc. Fort Wayne, Indiana  46815
Mahendra M. Shah, MD, FACP Hammond, Indiana  46320
Iowa Blood and Cancer Care, PLC Cedar Rapids, Iowa  52402
Heartland Oncology & Hematology, LLP Council Bluffs, Iowa  51503
Drs.Caroll, Sheth and Raghavan Louisville, Kentucky  40215
The Center for Clinical Research Hagerstown, Maryland  21740
NW MS Hem/Onc (Tupelo) Tupelo, Mississippi  38801
Columbia Comprehensive Cancer Care Center Columbia, Missouri  65201
The Billings Clinic Billings, Montana  59101
Saint Francis Memoiral Hospital Grand Island, Nebraska  68803
Nebraska Hematology-Oncology,PC Lincoln, Nebraska  68506
Cancer Care at St. Claire's Denville, New Jersey  07834
Northern Valley Medical Westwood, New Jersey  07675
Hematology Oncology Assoc. of W. Suffolk, PC Bay Shore, New York  11706
North Shore Hematology Oncology Assoc. E. Setauket, New York  11733
Cancer Center of North Carolina Raleigh, North Carolina  27614
MeritCare Clinical Research Fargo, North Dakota  58122
Tricounty Hem/Onc Associates Canton, Ohio  44718
Hematology-Oncology Consultants, Inc Columbus, Ohio  43235
Greater Philadelphia Cancer Center Philadelphia, Pennsylvania  19114
Carolina Health Care Florence, South Carolina  29501
Mid-South Cancer Center Germantown, Tennessee  38138
Mid-South Cancer Center, PC Germantown, Tennessee  38138
Kingsport Hematology Oncology Kingsport, Tennessee  37660
Boston Baskin Cancer Group D/B/A/ UTCI Memphis, Tennessee  38104
Texas Oncology Cancer Center, PA Austin, Texas  78731
Mitchell Medical Clinic Daingerfield, Texas  75638
Clinical Oncology & Hematology, LLP Dallas, Texas  75235
Sacred Heart Medical Center - Providence Cancer Care Center Spokane, Washington  99204