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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 WisconsinMilwaukee, Wisconsin  53226
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Harrington Cancer CenterAmarillo, Texas  79106
Providence Alaska Medical CenterAnchorage, Alaska  99508
Virginia Oncology AssociatesNewport News, Virginia  23606
Trinity Cancer Care CenterMinot, North Dakota  58701
Rocky Mountain Cancer CenterDenver, Colorado  80218
Ocala Oncology CenterOcala, Florida  34474
Green Bay Oncology, Ltd.Green Bay, Wisconsin  54307-3453
Florida Cancer SpecialistsFort Myers, Florida  33901
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut  06360
Pacific Shores Medical GroupLong Beach, California  90813
Lakeland Regional Medical CenterLakeland, Florida  33804
Gaston Hematology and OncologyGastonia, North Carolina  28054
Genesis Cancer CenterHot Springs, Arkansas  71913
Center for Hematology-OncologyBoca Raton, Florida  33486
Medical Oncology Care AssociatesOrange, California  92668
Cancer Care AssociatesTulsa, Oklahoma  74136
Associates in Oncology/HematologyRockville, Maryland  20850
Center for Oncology Research and TreatmentDallas, Texas  75230
Northern Utah AssociatesOgden, Utah  84403
Stockton Hematology Oncology Medical GroupStockton, California  95204
Lahey ClinicBurlington, Massachusetts  01805
University of ChicagoChicago, Illinois  60637
Urology Centers Of AlabamaHomewood,, Alabama  35205
Texas OncologyDallas, Texas  
Pacific Hematology Oncology AssociatesSan Francisco, California  94115
Santa Barbara Hematology Oncology Medical GroupLompoc, California  93438
North Valley Hematology/Oncology Medical GroupNorthridge, California  91328
Cancer & Hematology Centers of Western MichiganGrand Rapids, Michigan  49546
Allison Cancer CenterMidland, Texas  79701
Peninsula Cancer InstituteNewport News, Virginia  23601
Sharp Clinical Oncology ResearchSan Diego, California  92123
Hematology Oncology Associates of Northern New JerseyMorristown, New Jersey  07960
The Jones ClinicGermantown, Tennessee  38138
Center for Cancer and Blood DisordersBethesda, Maryland  20817
The Mary Imogene Bassett HospitalCooperstown, New York  13326
St. Johns Mercy Medical CenterSt. Louis, Missouri  63141
Birmingham Hematology and OncologyBirmingham, Alabama  35235
Texas Cancer CenterAbilene, Texas  79606
Ephrata Cancer CenterEphrata, Pennsylvania  17522
East Valley Hematology Oncology Medical GroupBurbank, California  91505
Dallas Oncology Consultants, PADallas, Texas  75237
The Center for Cancer Care & ResearchSt. Louis, Missouri  63141
Northwest Cancer Specialists, PCVancouver, Washington  98684
Cedar Valley Medical SpecialistsWaterloo, Iowa  50702
Cancer Specialists of OklahomaOklahoma City, Oklahoma  73112
Oncology Associates of BridgeportTrumball, Connecticut  06611
Kalamazoo Hematology and OncologyKalamazoo, Michigan  49048
Gainesville Hematology Oncology AssociatesGainesville, Florida  32605
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
McLeod Cancer and Blood CenterJohnson City, Tennessee  37604
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Jackson Oncology AssociatesJackson, Mississippi  39202
Connecticut Oncology & Hematology, LLPTorrington, Connecticut  06790
Ohio Cancer SpecialistsMansfield, Ohio  44907
Lone Star Oncology ConsultantsAustin, Texas  78759
Richmond University Medical CenterStaten Island, New York  10310-1699
Pacific Cancer Medical Center, IncAnaheim, California  92801
Lancaster Cancer Center, Ltd.Lancaster, Pennsylvania  17601
The Christ HospitalCincinnati, Ohio  45219
Mid-Ohio Oncology/HematologyColumbus, Ohio  43219
Mcfarland Clinic PcAmes, Iowa  50010
Carraway Cancer ClinicBirmingham, Alabama  35234
Clopton ClinicJonesboro, Arkansas  72401
Michael Harris MDMission Viejo, California  92691
Newport Cancer Care Medical Assoc., Inc.Newport Beach, California  92663
Desert Cancer CenterRancho Mirage, California  92270
Santa Barbara HemotologySanta Barbara, California  93105
Sierra Nevada OncologyTruckee, California  96161
Medical Specialists of Fairfield, LLCFairfield, Connecticut  06284
Davis, Posteraro, and Wasser, MDs, LLPManchester, Connecticut  06040
Whittigham Cancer Center at Norwalk HospitalNorwalk, Connecticut  06856
Hematology OncologyStamford, Connecticut  06902
Florida Cancer SpecalistsBradenton, Florida  34209
Florida Cancer Care Specialists-Fort Myers Summerlin OfficeFort Myers, Florida  33908
ICONJacksonville, Florida  32256
MIMA Century Research Assoc.Melbourne, Florida  32901
Marc I. SaltzmanMiami, Florida  33138
Mid-Florida Hematology & Oncology CentersOrange City, Florida  32763
Sacred Heart Hospital Cancer ResearchPensacola, Florida  32504
Notheast Georgia Cancer Care, LLCAthens, Georgia  30607
Medical Oncology Assoc. of Augusta, PCAugusta, Georgia  30901
GA UrologyDecatur, Georgia  30033
Suburban Hematology-Oncology Assoc., PCLawrenceville, Georgia  30045
Medical & Surgical Spealists, LLCGalesburg, Illinois  61401
Urology Associates, S.C.Mattoon, Illinois  61938
Mid-Illinois Hematology and Oncology Assoc., LTDNormal, Illinois  61761
Oncology Hematology Associates of Central IL, PCPeoria, Illinois  61615
Fort Wayne Medical Oncology Hematology, Inc.Fort Wayne, Indiana  46815
Mahendra M. Shah, MD, FACPHammond, Indiana  46320
Iowa Blood and Cancer Care, PLCCedar Rapids, Iowa  52402
Heartland Oncology & Hematology, LLPCouncil Bluffs, Iowa  51503
Drs.Caroll, Sheth and RaghavanLouisville, Kentucky  40215
The Center for Clinical ResearchHagerstown, Maryland  21740
NW MS Hem/Onc (Tupelo)Tupelo, Mississippi  38801
Columbia Comprehensive Cancer Care CenterColumbia, Missouri  65201
The Billings ClinicBillings, Montana  59101
Saint Francis Memoiral HospitalGrand Island, Nebraska  68803
Nebraska Hematology-Oncology,PCLincoln, Nebraska  68506
Cancer Care at St. Claire'sDenville, New Jersey  07834
Northern Valley MedicalWestwood, New Jersey  07675
Hematology Oncology Assoc. of W. Suffolk, PCBay Shore, New York  11706
North Shore Hematology Oncology Assoc.E. Setauket, New York  11733
Cancer Center of North CarolinaRaleigh, North Carolina  27614
MeritCare Clinical ResearchFargo, North Dakota  58122
Tricounty Hem/Onc AssociatesCanton, Ohio  44718
Hematology-Oncology Consultants, IncColumbus, Ohio  43235
Greater Philadelphia Cancer CenterPhiladelphia, Pennsylvania  19114
Carolina Health CareFlorence, South Carolina  29501
Mid-South Cancer CenterGermantown, Tennessee  38138
Mid-South Cancer Center, PCGermantown, Tennessee  38138
Kingsport Hematology OncologyKingsport, Tennessee  37660
Boston Baskin Cancer Group D/B/A/ UTCIMemphis, Tennessee  38104
Texas Oncology Cancer Center, PAAustin, Texas  78731
Mitchell Medical ClinicDaingerfield, Texas  75638
Clinical Oncology & Hematology, LLPDallas, Texas  75235
Sacred Heart Medical Center - Providence Cancer Care CenterSpokane, Washington  99204