A phase I study of sunitinib plus capecitabine in patients with advanced solid tumors.

ABSTRACT:

Purpose

This open-label, phase I, dose-escalation study assessed the maximum-tolerated dose (MTD), safety, pharmacokinetics, and antitumor activity of sunitinib in combination with capecitabine in patients with advanced solid tumors.

Patients and methods

Sunitinib (25, 37.5, or 50 mg) was administered orally once daily on three dosing schedules: 4 weeks on treatment, 2 weeks off treatment (Schedule 4/2); 2 weeks on treatment, 1 week off treatment (Schedule 2/1); and continuous daily dosing (CDD schedule). Capecitabine (825, 1,000, or 1,250 mg/m(2)) was administered orally twice daily on days 1 to 14 every 3 weeks for all patients. Sunitinib and capecitabine doses were escalated in serial patient cohorts.

Results

Seventy-three patients were treated. Grade 3 adverse eve

SUBMITTER: Sweeney CJ 

PROVIDER: S-EPMC2988641 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature