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Phase I Study of S-1 Combined with Irinotecan (CPT-11) in Patients with Advanced Colorectal Cancer.
Oncology. 2007 Nov 13;72(1-2):58-63
Authors: Tsunoda A, Yasuda N, Nakao K, Narita K, Yamazaki K, Watanabe M, Suzuki N, Kusano M
Purpose: To determine the maximum tolerated dose, recommended dose and dose-limiting toxicities of irinotecan plus S-1 in advanced colorectal cancer. Patients and Methods: S-1 was administered orally at 80 mg/m(2)/day for 21 consecutive days followed by a 2-week rest. CPT-11 was given intravenously on days 1 and 15 of each course, at an initial dose of 60 mg/m(2)/day, stepping up to 80, 100, 120 or 140 mg/m(2)/day. Courses were repeated every 5 weeks, unless disease progression or severe toxicities were observed. Results: A total of 20 patients were entered in this study. The maximum tolerated dose of CPT-11 was considered to be 100 mg/m(2), because 2 of 3 patients developed dose-limiting toxicities, such as anorexia, fatigue and diarrhea. Therefore, the recommended dose of CPT-11 was set at 80 mg/m(2). Tumor responses were seen in 8 of 14 patients with measurable lesions. Conclusion: A combination of S-1 with CPT-11 is safe and can be recommended for further phase II studies in patients with advanced colorectal cancer. Copyright © 2007 S. Karger AG, Basel.
PMID: 17998791 [PubMed - as supplied by publisher] (Source: Oncology)

Posted on Tue, 13 Nov 2007 05:00:00 +0100 at http://www.ncbi.nlm.nih.gov/entrez/query...t=Abstract
Author: Oncology
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