Phase III trial of carboplatin and paclitaxel with or without sorafenib in metastatic melanoma.

ABSTRACT:

Purpose

The primary objective of this study was to determine whether carboplatin, paclitaxel, and sorafenib (CPS) improve overall survival (OS) compared with carboplatin and paclitaxel (CP) in chemotherapy-naive patients with metastatic melanoma.

Patients and methods

In this double-blind, randomized, placebo-controlled phase III study, all patients received carboplatin at area under the [concentration-time] curve 6 and paclitaxel 225 mg/m(2) intravenously once every 21 days with random assignment to sorafenib 400 mg orally twice per day on days 2 through 19 every 21 days or placebo. The primary end point was OS, and secondary end points included progression-free survival, objective tumor response, and toxicity.

Results

In all, 823 patients were enrolled over 34 months

SUBMITTER: Flaherty KT 

PROVIDER: S-EPMC4878104 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature