A phase I trial of the oral, multikinase inhibitor sorafenib in combination with carboplatin and paclitaxel.

Publication Type:

Journal Article


Clinical cancer research : an official journal of the American Association for Cancer Research, Volume 14, Issue 15, p.4836-42 (2008)


2008, Administration, Oral, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Benzenesulfonates, Biopsy, Carboplatin, Clinical Research Division, Female, Humans, Male, Maximum Tolerated Dose, Middle Aged, paclitaxel, Public Health Sciences Division, Pyridines, Time Factors, Treatment Outcome


This study evaluated the safety, maximum tolerated dose, pharmacokinetics, and antitumor activity of sorafenib, a multikinase inhibitor, combined with paclitaxel and carboplatin in patients with solid tumors. Patients and Methods: Thirty-nine patients with advanced cancer (24 with melanoma) received oral sorafenib 100, 200, or 400 mg twice daily on days 2 to 19 of a 21-day cycle. All patients received carboplatin corresponding to AUC6 and 225 mg/m(2) paclitaxel on day 1. Pharmacokinetic analyses were done for sorafenib on days 2 and 19 of cycle 1 and for paclitaxel on day 1 of cycles 1 and 2. Pretreatment tumor samples from 17 melanoma patients were analyzed for BRAF mutations.