Capecitabine in combination with mitomycin C in patients with gastrointestinal cancer: results of an extended multicentre phase-I trial

British Journal of Cancer
R-D HofheinzA Hochhaus

Abstract

The aim of this study was to determine the dose-limiting toxicity (DLT) and establish the recommended dose for mitomycin C added every 3 weeks to the standard combination dose of capecitabine. Cohorts of at least three patients with pretreated gastrointestinal carcinoma received capecitabine 1000 mg m(-2) orally twice daily on days 1-14 plus i.v. bolus mitomycin C on day 1 at doses of 4, 6, 8 or 10 mg m(-2) (corresponding to dose levels I-IV). Cycles were repeated every 3 weeks. Two treatment cycles were considered for the evaluation of DLTs. Of the 53 patients enrolled, the majority had colorectal (n=27) or gastric (n=14) cancers. Patients had received a median of two lines of prior chemotherapy (34% with >/=3 lines and 87% with prior 5-FU-based therapy). At the recommended dose level (IV, n=30), grade 3 adverse events during cycles 1 and 2 were: anaemia (10%); leukopenia (3%); thrombocytopenia (3%); stomatitis/mucositis (3%); hand-foot syndrome (3%). Two patients experienced DLTs (mucositis, n=1; neutropenic fever, n=1), but there were no grade 4 events. The median dose intensity for capecitabine and mitomycin C was 100% during cycles 1 and 2 and only four patients required postponement of therapy. Of the 43 patients evaluabl...Continue Reading

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Citations

Dec 15, 2005·Journal of Surgical Oncology·Yutaka OgataKazuo Shirouzu
May 4, 2010·Expert Opinion on Investigational Drugs·Anastasios DimouMuhammad Wasif Saif
Feb 22, 2014·Journal of Cancer Research and Clinical Oncology·Manuel Barreto MirandaKirsten Merx
Jun 10, 2011·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E Van CutsemJ Zalcberg

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