A phase II study of gefitinib in combination with FOLFOX-4 (IFOX) in patients with metastatic colorectal cancer

Abstract

3514 Background: Gefitinib (ZD1839, Iressa) is an inhibitor of epidermal growth factor receptor-1 and has been shown to produce growth inhibition and shrinkage in human tumors. Here we report the preliminary results of a trial to evaluate the efficacy and toxicity of Gefitinib (I) with FOLFOX-4 in patients (pts) with advanced colorectal cancer. Methods: Each cycle consisted of 14 days. Cycle 1 consisted of FOLFOX-4 while cycle 2 and subsequent cycles consisted of FOLFOX-4 with gefitinib at 500 mg PO qd. Pts were stratified by prior therapy for metastatic disease; Group A with no prior therapy and Group B with prior therapy Results: 56 pts have been enrolled (Group A: N=32; Group B: N=24) to date. Median age 54 years (range, 37–79) and median ECOG PS 0 (range 0–1). No patient had prior oxaliplatin. 359 cycles have been administered to date. All pts were assessable for toxicity and 49 were assessable for response. Two pts withdrew prior to completing 4 cycles due to unacceptable toxicity. Grade 3/4 toxiciti...