A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel

RATIONALE: Satraplatin is an oral platinum analog that is currently being evaluated in combination with prednisone in a phase III clinical trial in patients with HRPC who have progressed following one prior chemotherapy regimen. Docetaxel is a taxane that is indicated for the treatment of patients with non-small cell lung, breast, and prostate cancers. Specifically, it was recently approved in combination with prednisone for the treatment of patients with hormone refractory prostate cancer (HRPC). Docetaxel administered every 3 weeks was associated with a survival advantage versus mitoxantrone. Docetaxel administered weekly showed an improvement in survival versus mitoxantrone that was not statistically significant. However, it was better tolerated than docetaxel administered every 3 weeks, with significantly less grade 3 and 4 toxicities, especially neutropenia. The combination of satraplatin and weekly docetaxel may be a feasible regimen for patients with chemotherapy-naïve HRPC and for patients with other malignancies for which these medications show activity. OBJECTIVE: The objective of this study is to determine the optimum doses for satraplatin and weekly docetaxel when the 2 drugs are given in combination.