A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel
| Status: | Archived |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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 ï‚£ 2 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.
We found this trial at
1
site
Sarah Cannon Cancer Center People who live with cancer
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