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

Study Overview
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Brief Summary
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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
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*****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.

Official Title
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Expanded Access Study of Satraplatin Plus Prednisone in Patients With Hormone Refractory Prostate Cancer (HRPC) Previously Treated With Unlimited Cytotoxic Chemotherapy Regimen (SPERA)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Oral Satraplatin


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: Oral Satraplatin<br>* The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.<br>|
| Experimental: 2<br>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. | Drug: Oral Satraplatin<br>* The SPERA protocol states that satraplatin may be continued until evidence of disease progression (at the discretion of the investigator), intolerable toxicity, withdrawal of informed consent, or non compliance. The treatment consists of satraplatin 80 mg/m2 administered by mouth once daily for five consecutive days (days 1-5) plus prednison 5 mg po twice daily. The treatment cycle is repeated every 35 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone Refractory Prostate Cancer (HRPC), Hormone Refractory Prostate Cancer, Unlimited Prior Cytotoxic Chemotherapy Regimens