None listed
Conditions
Interventions
satraplatin + prednisone Type of group
satraplatin 100 mg/m2/d for 5 days plus BID administration of 10 mg prednisone for 5 days.
Group name:placebo + prednisone Type of group
Placebo plus BID administration of 10 mg prednisone alone for 5 days (N = 7).
Sponsors
GPC BIOTECH INC.,
Eligibility
Inclusion criteria
Inclusion criteria: Metastatic prostate cancer in stage D2 Progression after previous chemotherapy ECOG performance status equal / less than 2 Life expectancy> 3 months Surgical or medical castration Adequate functions of bone marrow, liver and kidney Informed consent
Exclusion criteria
Exclusion criteria: More than one prior chemotherapy Previous compounds containing platinum Previous malignancy Previous RT / radionuclide therapy Major surgery GI or GI disease that affects absorption Disease with contraindication for steroids Brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Countries
Canada, Japan, Peru, Switzerland, United Kindgdom, United States
Outcome results
None listed