Phase I/II study of gefitinib and capecitabine in patients with colorectal cancer.

Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico
A JimenoH Cortés-Funes

Abstract

The objectives of this phase I/II study were to determine the maximum tolerated dose (MTD), characterise the principal toxicities in the phase I part and assess the efficacy in the phase II part of gefitinib, an oral selective inhibitor of the epidermal growth factor receptor, in combination with capecitabine in patients with advanced colorectal cancer (CRC). Patients with advanced CRC were treated with gefitinib administered daily for 21 days and capecitabine administered twice daily for 14 days of a 21-day cycle. The dose levels of gefitinib (mg) and capecitabine (mg/m(2) bid) assessed were 250/1000 and 250/ 1250. An expanded cohort was enrolled at the MTD to better characterise toxicity and efficacy. A total of 32 previously treated patients were accrued. In the phase I part 10 subjects were treated, with one dose-limiting toxicity. Overall 26 patients were treated at the MTD of the combination, which was gefitinib 250 mg/day and capecitabine 1250 mg/m(2) twice daily. The most frequent treatment-related adverse events included asthenia, diarrhoea, nausea, rash and anorexia. The incidence profile was very similar in phases I and II. No objective responses were documented but 53% of the patients achieved stable disease as best...Continue Reading

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Citations

Apr 12, 2011·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Li YangHoujie Liang
Apr 14, 2012·Drug Metabolism Reviews·Jose J G MarinOscar Briz
Dec 18, 2013·Seminars in Diagnostic Pathology·Andrew M Bellizzi
Nov 28, 2013·Pharmaceuticals·Christina Leah B Kline, Wafik S El-Deiry

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