A phase 1/1b study of satraplatin (JM-216) in combination with docetaxel in patients with advanced solid tumors and metastatic castrate-resistant prostate cancer - Abstract

University of Wisconsin Carbone Cancer Center, Wisconsin Institutes for Medical Research, Madison, WI 53705, USA.

 

Satraplatin is an oral platinum with potential advantages over other platinum agents. This study investigated the combination of satraplatin and docetaxel in a phase 1 study of patients with advanced solid tumor malignancies followed by a phase 1b study in men with chemotherapy naïve metastatic castrate-resistant prostate cancer (CRPC).

In this single institution phase 1/1b study, patients received docetaxel on day 1 and satraplatin on days 1-5 of a 21-day cycle ± granulocyte colony stimulating factor (GCSF). For phase 1b, prednisone 10 mg daily was added.

Twenty-nine patients received treatment. Based on 3 dose limiting toxicities (DLT) (grade 4 neutropenia) in 13 patients at dose levels 1 and -1 (docetaxel 60 mg/m(2) plus satraplatin 40 mg/m(2) and docetaxel 60 mg/m(2) plus satraplatin 50 mg/m(2)) GCSF was administered with subsequent cohorts. A dose level of docetaxel 60 mg/m(2) plus satraplatin 50 mg/m(2) with GCSF was the starting dose level for phase 1b. At the highest dose in the phase 1b (docetaxel 75 mg/m(2) plus satraplatin 50 mg/m(2)) there were no DLTs.

The combination of satraplatin and docetaxel is feasible in solid tumor malignancies. In advanced malignancies, the recommended phase 2 dose is docetaxel 60 mg/m(2) IV day 1 with satraplatin 40 mg/m(2)/d PO days 1-5, without G-CSF, and Docetaxel 70 mg/m(2) IV day 1 with Satraplatin 50 mg/m(2)/day PO days 1-5, with G-CSF support, repeated in 3-week cycles. For patients with CRPC the recommended phase 2 dose is docetaxel 75 mg/m(2) IV day 1 with satraplatin 50 mg/m(2)/d PO days 1--5, with G-CSF and prednisone 10 mg daily, repeated in 3-week cycles.

Written by:
Cetnar J, Wilding G, McNeel D, Loconte NK, McFarland TA, Eickhoff J, Liu G.   Are you the author?

Reference: Urol Oncol. 2011 Apr 8. Epub ahead of print.
doi: 10.1016/j.urolonc.2011.02.007

PubMed Abstract
PMID: 21481618

UroToday.com Prostate Cancer Section

 

 

email news signup