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

Phase 3

Terminated

Brief Summary: 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.

Detailed Description: \*\*\*\*\*UPDATE\*\*\*\*\* On October 30th, 2007 GPC Biotech announced topline overall survival results for the Phase III trial in hormone refractory prostate cancer-Satraplatin and Prednisone Against Refractory Cancer (SPARC) trial.

The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis). The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The companies are currently conducting pre-specified subset analyses.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
1	Oral Satraplatin	Prednisone and Satraplatin (INN / USAN), also known as JM-216, or OC-6-43-bis(acetato-O)ammine dichloro (cyclohexanamine)-platinum (IV), is a member of a novel class of platinum (IV) compounds that are absorbed by the oral route. The lipophilic properties of these compounds, and hence their absorption, are largely determined by the nature of the axial acetate ligands.
2	Oral Satraplatin	Prednisone (17 alpha, 21-dihydroxypregna-1, 4-diene-3, 11, 20-trione) is commercially formulated as the acetate salt (prednisone 21-acetate). It is a biologically inert glucocorticoid, which is converted to active prednisolone in the liver.

Primary Outcome Measures

Name	Time	Method
The SPERA trial is designed to provide satraplatin to physicians with patients who have hormone refractory prostate cancer (HRPC) which has progressed following unlimited prior cytotoxic chemotherapy regimens for metastatic disease.	Patient evaluation by MD at baseline to determine eligibility.

Secondary Outcome Measures

Name	Time	Method

Locations (119): Carraway Cancer Clinic
🇺🇸
Birmingham, Alabama, United States
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
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Carraway Cancer Clinic
🇺🇸Birmingham, Alabama, United States