Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC)

Stopped early · Phase 3

Conditions studied: Prostate Cancer

In brief

The SPERA trial is designed to 1. provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited cytotoxic chemotherapy regimens for metastatic disease and 2. to evaluate the safety of oral satraplatin in this patient population.

Key facts

Study ID

NCT00450970

Run by

Agennix

People needed

344

Starts

2007-02-01

Expected to finish

2009-12-01

Last updated by the study team

2012-08-17

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Birmingham Hematology and Oncology — Birmingham, Alabama, United States
• Urology Centers of Alabama — Homewood, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Clopton Clinic — Jonesboro, Arkansas, United States
• Pacific Cancer Medical Center, Inc — Anaheim, California, United States
• East Valley Hematology Oncology Medical Group — Burbank, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• North Valley Hematology/Oncology Medical Group — Mission Hills, California, United States
• Michael Harris MD — Mission Viejo, California, United States
• Newport Cancer Care Medical Assoc., Inc. — Newport Beach, California, United States
• Medical Oncology Care Associates — Orange, California, United States
• Desert Cancer Center — Rancho Mirage, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Santa Barbara Hematology Oncology Medical Group — Santa Barbara, California, United States
• Santa Barbara Hemotology — Santa Barbara, California, United States
• Stockton Hematology Oncology Medical Group — Stockton, California, United States
• Sierra Nevada Oncology — Truckee, California, United States
• Rocky Mountain Cancer Center — Colorado Springs, Colorado, United States
• Oncology Associates of Bridgeport — Bridgeport, Connecticut, United States
• Medical Specialists of Fairfield, LLC — Fairfield, Connecticut, United States
• Davis, Posteraro, and Wasser, MDs, LLP — Manchester, Connecticut, United States
• Whittigham Cancer Center at Norwalk Hospital — Norwalk, Connecticut, United States
• Carraway Cancer Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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