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- Title
Phase I Study of S-1 Combined with Irinotecan (CPT-11) in Patients with Advanced Colorectal Cancer.
- Authors
Tsunoda, A.; Yasuda, N.; Nakao, K.; Narita, K.; Yamazaki, K.; Watanabe, M.; Suzuki, N.; Kusano, M.
- Abstract
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/m2/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/m2/day, stepping up to 80, 100, 120 or 140 mg/m2/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/m2, 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/m2. 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
- Subjects
COLON cancer; CANCER patients; CLINICAL medicine research; APPETITE loss; FATIGUE (Physiology); DIARRHEA
- Publication
Oncology, 2007, Vol 72, Issue 1/2, p58
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000111095