Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

NCT00069745 — Phase 3, Completed, Agennix
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A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen

RegistryNCT00069745
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
SponsorAgennix (Industry)
ConditionsProstate Cancer, Hormone Refractory Prostate Cancer
InterventionsSatraplatin, Prednisone (Drug)
Datesstart 2003-09-01, primary completion 2006-01-01, completion 2007-03-01, first posted 2003-10-06, last updated 2012-08-07
Locations211 sites in United States, Argentina, Belgium, Croatia, France, Germany, Hungary, Israel and 7 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Prostate Cancer All trials for Hormone Refractory Prostate Cancer All trials of Satraplatin All trials of Prednisone

-Summary

PURPOSE:

The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

TARGET PATIENT POPULATION:

The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN:

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. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.

RATIONALE:

There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy

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+Arms and interventions

  • Satraplatin (Drug)
  • Prednisone (Drug)

+Eligibility

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

* Stage D2 metastatic prostate cancer
* Progression after one prior chemotherapy
* ECOG Performance status equal / less than 2
* Life expectancy > 3 months
* Surgical or medical castration
* Adequate bone marrow, hepatic and renal functions
* Informed consent

Exclusion Criteria:

* More than one prior chemotherapy
* Prior platinum containing compounds
* Prior malignancy
* Prior significant RT/radionuclide therapy
* Major GI surgery or GI disease affecting absorption
* Disease with contraindication to steroids
* Brain metastases

+Locations (211)

FacilityCityCountryStatus
Birmingham Hematology and OncologyBirmingham, AlabamaUnited States
Birmingham Hematology and OncologyBirmingham, AlabamaUnited States
Hematology Oncology AssociatesPhoenix, ArizonaUnited States
Northern AZ Hematology & Oncology Assoc.Sedona, ArizonaUnited States
Hematology Oncology Physicians/SMOTucson, ArizonaUnited States
Arizona Cancer CenterTuscon, ArizonaUnited States
California Cancer CenterFresno, CaliforniaUnited States
Pacific Shores Medical GroupLong Beach, CaliforniaUnited States
Division of Hematology - OncologyLos Angeles, CaliforniaUnited States
University of California Davis Cancer Center, Division of Hematology-OncologySacramento, CaliforniaUnited States
Sharp Healthcare - Clinical Oncology ResearchSan Diego, CaliforniaUnited States
Rocky Mountain Cancer Center - MidtownDenver, ColoradoUnited States
Hartford HospitalHartford, ConnecticutUnited States
DeQuattro Community Cancer CenterManchester, ConnecticutUnited States
Cancer Centers of Florida-AltamonteAltamonte Springs, FloridaUnited States
The Center for Hematology OncologyBoca Raton, FloridaUnited States
Hematology/Oncology Group of South FloridaMiami, FloridaUnited States
Innovative Medical Research of South FloridaMiami Shores, FloridaUnited States
Florida Cancer InstituteNew Port Richey, FloridaUnited States
Ocala Oncology CenterOcala, FloridaUnited States
South Florida Oncology & HematologyPlantation, FloridaUnited States
Hematology/Oncology Associates of Treasure CoastPort Saint Lucie, FloridaUnited States
Oncology and Hematology Associates of West Broward P.A.Tamarac, FloridaUnited States
Decatur Memorial HospitalDecatur, IllinoisUnited States
Northwest Medical SpecialistsNiles, IllinoisUnited States
North Shore Research AssociationSkokie, IllinoisUnited States
Central Indiana Cancer CentersFishers, IndianaUnited States
Indiana Hematology Oncology ConsultantsIndianapolis, IndianaUnited States
Central Indiana Cancer CentersIndianapolis, IndianaUnited States
Oncology Associates of Cedar RapidsCedar Rapids, IowaUnited States
Kansas City Cancer Centers - SouthwestOverland Park, KansasUnited States
Louisiana Oncology AssociatesLafayette, LouisianaUnited States
LSU Health Science Center, Stanley S. Scott Cancer CenterNew Orleans, LouisianaUnited States
Maine Center for Cancer Medicine & Blood DisordersScarborough, MaineUnited States
Berkshire Hematology OncologyPittsfield, MassachusettsUnited States
Karmanos Cancer Institute, Wayne State UniversityDetroit, MichiganUnited States
Maplewood Cancer CenterMaplewood, MinnesotaUnited States
Virginia Piper Cancer InstituteMinneapolis, MinnesotaUnited States
Missouri Cancer AssociatesColumbia, MissouriUnited States
Capitol Comprehensive Cancer Care ClinicJefferson City, MissouriUnited States
St. Joseph Oncology, Inc.Saint Joseph, MissouriUnited States
Hematology/Oncology Consultants, Inc.St Louis, MissouriUnited States
Arch Medical Services, Inc.Washington, MissouriUnited States
Nebraska Methodist Hospital Cancer CenterOmaha, NebraskaUnited States
Comprehensive Cancer Centers of NevadaLas Vegas, NevadaUnited States
Nevada Cancer InstituteLas Vegas, NevadaUnited States
New Hampshire Oncology-Hematology PAHooksett, New HampshireUnited States
Hematology Oncology AssociatesAlbuquerque, New MexicoUnited States
Lovelace Sandia Health SystemsAlbuquerque, New MexicoUnited States
Veterans Affairs Medical CenterAlbuquerque, New MexicoUnited States
The University of New MexicoAlbuquerque, New MexicoUnited States
New Mexico Cancer Care AssociatesSanta Fe, New MexicoUnited States
Albany Regional Cancer CenterAlbany, New YorkUnited States
New York Oncology Hematology, P.C.Albany, New YorkUnited States
Advanced Oncology AssociatesArmonk, New YorkUnited States
Roswell Park Cancer InstituteBuffalo, New YorkUnited States
Interlakes Oncology HematologyCanandaigua, New YorkUnited States
Columbia Presbyterian Medical CenterNew York, New YorkUnited States
New York Oncology HematologyRexford, New YorkUnited States
VA Medical Center SyracuseSyracuse, New YorkUnited States
Raleigh Hematology Oncology ClinicCary, North CarolinaUnited States
Piedmont Hematology - OncologyWinston-Salem, North CarolinaUnited States
Dayton Oncology HematologyKettering, OhioUnited States
Cancer Care AssociatesOklahoma City, OklahomaUnited States
Cancer Care AssociatesTulsa, OklahomaUnited States
Willamette Valley Cancer CenterEugene, OregonUnited States
Hematology and Oncology Associates of Northeastern PA / PCDunmore, PennsylvaniaUnited States
University of Pennsylvania Abramson Cancer CenterPhiladelphia, PennsylvaniaUnited States
University of Pittsburgh Cancer Institute- Hillman Cancer CenterPittsburgh, PennsylvaniaUnited States
Charleston Cancer CenterCharleston, South CarolinaUnited States
Medical University of South Carolina Hollings Cancer CenterCharleston, South CarolinaUnited States
Cancer Center of the Carolinas, SenecaSeneca, South CarolinaUnited States
The West ClinicMemphis, TennesseeUnited States
Texas Cancer CenterAbilene, TexasUnited States
Texas OncologyArlington, TexasUnited States
Southwest Regional Cancer CenterAustin, TexasUnited States
Texas Oncology Cancer CenterAustin, TexasUnited States
Mamie McFaddin Ward Cancer CenterBeaumont, TexasUnited States
Texas Onoclogy PA - BedfordBedford, TexasUnited States
Texas Cancer Center at Medical CityDallas, TexasUnited States
Texas Oncology, P.A.Dallas, TexasUnited States
The Texas Cancer CenterDallas, TexasUnited States
TOPA Sammons Cancer CenterDallas, TexasUnited States
Texas Cancer CenterDenton, TexasUnited States
El Paso Cancer Treatment CenterEl Paso, TexasUnited States
Texas Oncology, P.A.Fort Worth, TexasUnited States
San Antonio Tumor & Blood ClinicFredericksburg, TexasUnited States
Texas Oncology, P.A.Garland, TexasUnited States
Texas Oncology, P.A. - IrvingIrving, TexasUnited States
Lake Vista Cancer CenterLewisville, TexasUnited States
Longview Cancer CenterLongview, TexasUnited States
S. Texas Cancer CenterMcAllen, TexasUnited States
Texas Cancer Center of MesquiteMesquite, TexasUnited States
Allison Cancer CenterMidland, TexasUnited States
West Texas Cancer CenterOdessa, TexasUnited States
Hematology Oncology Associates of South TexasSan Antonio, TexasUnited States
Tyler Cancer CenterTyler, TexasUnited States
Waco Cancer Care Research CenterWaco, TexasUnited States
Texas Oncology, P.A. - Deke Slayton Cancer CenterWebster, TexasUnited States
Virginia Oncology AssociatesNorfolk, VirginiaUnited States

111 more sites not listed.