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

Completed · Phase 3

Conditions studied: Prostate Cancer, Hormone Refractory Prostate Cancer

In brief

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

Key facts

Study ID

NCT00069745

Run by

Agennix

Starts

2003-09-01

Expected to finish

2007-03-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Birmingham Hematology and Oncology — Birmingham, Alabama, United States
• Hematology Oncology Associates — Phoenix, Arizona, United States
• Northern AZ Hematology & Oncology Assoc. — Sedona, Arizona, United States
• Hematology Oncology Physicians/SMO — Tucson, Arizona, United States
• Arizona Cancer Center — Tuscon, Arizona, United States
• California Cancer Center — Fresno, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Division of Hematology - Oncology — Los Angeles, California, United States
• University of California Davis Cancer Center, Division of Hematology-Oncology — Sacramento, California, United States
• Sharp Healthcare - Clinical Oncology Research — San Diego, California, United States
• Rocky Mountain Cancer Center - Midtown — Denver, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• DeQuattro Community Cancer Center — Manchester, Connecticut, United States
• Cancer Centers of Florida-Altamonte — Altamonte Springs, Florida, United States
• The Center for Hematology Oncology — Boca Raton, Florida, United States
• Hematology/Oncology Group of South Florida — Miami, Florida, United States
• Innovative Medical Research of South Florida — Miami Shores, Florida, United States
• Florida Cancer Institute — New Port Richey, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• South Florida Oncology & Hematology — Plantation, Florida, United States
• Hematology/Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
• Oncology and Hematology Associates of West Broward P.A. — Tamarac, Florida, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Northwest Medical Specialists — Niles, Illinois, United States
• Birmingham Hematology and Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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