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

Publication Type:

Journal Article

Source:

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

Keywords:

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

Abstract:

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.