This is a single-center, open-label (sequential-group dose-escalation dose-finding) phase I study of satraplatin and docetaxel in patients who have received prior chemotherapy regimens. Once the MTD is determined, an additional 6 patients, all with chemotherapy-naïve HRPC, will be enrolled. Once a recommended dose(s) (RD(s)) for phase 2 studies has/have been determined, 6 additional patients with chemotherapy-naïve HRPC will be enrolled at the RD to further evaluate safety and efficacy.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Satraplatin is an oral platinum analogue that has shown promising activity in multiple tumor settings. Satraplatin (40 to 80 mg/m2/day) will be administered orally on days 1 to 5 of a 21 day cycle.
Sarah Cannon Research Institute
Nashville, Tennessee, United States
To assess the maximum tolerated dose (MTD) of satraplatin administered every 4 weeks in combination with docetaxel administered weekly (3 of 4 weeks)
Time frame: 30 days
To assess safety and tolerability (as per NCI-CTCAE version 3.0)
Time frame: 30 days
To assess preliminary antitumor activity
Time frame: 6 months
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