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

Phase 3

Completed

• Conditions: Prostate Cancer; Hormone Refractory Prostate Cancer

• Registration Number: NCT00069745
• Lead Sponsor: Agennix

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

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-09-30
• Study First Submitted QC: 2003-10-03
• Study First Posted: 2003-10-06
• Primary Completion: 2006-01
• Study Completion: 2007-03
• Disposition First Submitted: 2012-03-22
• Disposition First Submitted QC: 2012-04-27
• Disposition First Posted: 2012-05-01
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (204)

Birmingham Hematology and Oncology; 🇺🇸 Birmingham, Alabama, United States

Hematology Oncology Associates; 🇺🇸 Albuquerque, New Mexico, 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

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