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

Tracking Information
First Received Date ^ICMJE	September 30, 2003
Last Updated Date	September 10, 2007
Start Date ^ICMJE	September 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00069745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
Official Title ^ICMJE	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
Brief 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
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostate Cancer Hormone Refractory Prostate Cancer One Prior Cytotoxic Chemotherapy Regimen
Intervention ^ICMJE	Drug: Satraplatin Drug: Prednisone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date	March 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Belgium, Croatia, France, Germany, Hungary, Israel, Italy, Netherlands, Peru, Poland, Russian Federation, Spain, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00069745
Responsible Party
Study ID Numbers ^ICMJE	GPC SAT3-03-01
Study Sponsor ^ICMJE	GPC Biotech
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	GPC Biotech
Verification Date	March 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP