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
References
Jan 1, 1983·Chemical & Pharmaceutical Bulletin·A KonoH Ishitsuka
Jun 1, 1996·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Y TakebayashiT Aikou
Jan 1, 1997·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·G LiuE Warner
May 30, 1998·Biochemical Pharmacology·T IshikawaH Ishitsuka
Feb 3, 2000·Journal of the National Cancer Institute·P TherasseS G Gwyther
Apr 17, 2001·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·P M HoffR Wong
Jul 19, 2001·Bioorganic & Medicinal Chemistry Letters·A J BarkerL Richards
May 31, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Mace L RothenbergDaniel G Haller
Mar 18, 2004·British Journal of Cancer·E Van CutsemR L Schilsky
Jun 1, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paulo M HoffJames L Abbruzzese
Jul 23, 2004·The New England Journal of Medicine·David CunninghamEric Van Cutsem
Aug 20, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Timothy KuoBranimir I Sikic
Oct 26, 2005·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Sandra Van SchaeybroeckPatrick Johnston
Nov 3, 2005·Nature Clinical Practice. Oncology·Leonard B Saltz
Dec 20, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Mace L RothenbergRobert J Coffey
May 20, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Charles ErlichmanEric K Rowinsky
Jun 6, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Eduardo Díaz-RubioUNKNOWN Spanish Cooperative Group for the Treatment of Digestive Tumors Trial
Jun 6, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Rainer PorschenUNKNOWN AIO Colorectal Study Group
Jan 12, 2012·The Oncologist·Eduardo Díaz-RubioUNKNOWN Spanish Cooperative Group for the Treatment of Digestive Tumors
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
Jul 9, 2016·Journal of Pharmaceutical and Biomedical Analysis·Di WuHui Li
Nov 28, 2013·Pharmaceuticals·Christina Leah B Kline, Wafik S El-Deiry
Dec 20, 2018·Journal of Cellular and Molecular Medicine·Song-Lin HeLong-Qi Chen