%0 Journal Article %A R. MIBU %A S. TANAKA %A K. FUTAMI %A K. SHIMADA %A M. HOTOKEZAKA %A S. NAKAHARA %A H. ICHIMIYA %A H. KIDO %A Y. HIRANO %A T. KASHIWAGI %A T. EGUCHI %A K. MITSUKI %A K. MIZUMOTO %A M. TANAKA %T Phase I/II Study of Irinotecan and UFT for Advanced or Metastatic Colorectal Cancer %D 2007 %J Anticancer Research %P 2673-2677 %V 27 %N 4C %X The aim of this study was to determine the recommended dose of irinotecan in combination with the fixed dose of oral UFT as first-line therapy in patients with advanced or recurrent colorectal cancer, and to evaluate the response rate and overall survival as a phase II study. Patients and Methods: Thirteen patients were recruited into a phase I trial. Four doses of irinotecan ranging from 60 to 150 mg/m2/day were administered intravenously on day 1 and day 16 in combination with UFT given orally from day 2 to day 15. In a phase II study, 53 patients received at least one cycle of this therapy. Results: The recommended dose of this combination was determined as irinotecan 120 mg/m2/day and UFT 400 mg/m2/day. Dose-limiting toxicities were neutropenia and prolonged leucopenia. On an intent-to-treat analysis, the response rate in the phase II study was 24.5% (95% confidence interval 13.8% to 38.2%). The median overall survival time was 20.3 months (95% confidence interval, 15.0-22.8 months). Out of 20 patients with stable disease, 17 who received more than 4 cycles of the regimen lived longer than the other 3 patients who received fewer than 3 cycles (p=0.0353). Hematological adverse events were mainly grade 3/4 neutropenia observed in 6 out of 53 patients. Grade 3 non-hematological toxicities, such as diarrhea, anorexia, nausea/vomiting and alopecia were observed in 6 patients. Conclusion: Irinotecan combined with oral UFT was effective and well-tolerated. This regimen may be considered as a first-line therapy for advanced or metastatic colorectal cancer and may result in fairly long survival, even for patients with stable disease. %U https://ar.iiarjournals.org/content/anticanres/27/4C/2673.full.pdf