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- Title
Phase I trial of S-1 every other day in combination with gemcitabine/cisplatin for inoperable biliary tract cancer.
- Authors
Uwagawa, Tadashi; Sakamoto, Taro; Abe, Kyohei; Okui, Norimitsu; Hata, Daigo; Shiba, Hiroaki; Futagawa, Yasuro; Aiba, Keisuke; Yanaga, Katsuhiko
- Abstract
Purpose: To date, gemcitabine-based or fluoropyrimidine-based regimens are recommended for unresectable advanced biliary tract cancer. Then, we conducted a phase I study of gemcitabine/cisplatin and S-1 that is an oral fluoropyrimidine. The aim of this study was to determine the dose-limiting toxicity (DLT), maximum-tolerated dose, and a recommended phase II dose of S-1. Response was assessed as a secondary endpoint. Patients and methods: Patients who have been diagnosed with unresectable or postoperative recurrent biliary tract cancer received cisplatin (25 mg/m i.v. for 120 min) followed by gemcitabine (1,000 mg/m i.v. for 30 min) on days 1 and 8, and oral S-1 on alternate days; this regimen was repeated at 21-day intervals. A standard '3 + 3' phase I dose-escalation design was adopted. This study was registered with University hospital Medical Information Network (UMIN) Center in Japan, number UMIN000008415. Results: Twelve patients were evaluable in this study. No patients developed DLTs. Recommended dose of S-1 was 80 (<1.25 m), 100 (1.25 ≤ 1.5 m), and 120 mg (1.5 m≥) per day. One patient could achieve conversion to curative surgery. Conclusion: This phase I study was performed safely and demonstrated encouraging response.
- Subjects
COMBINATION drug therapy; BILIARY tract; CLINICAL trials; CISPLATIN; DEOXYCYTIDINE; FLUOROPYRIMIDINES; OPERATIVE surgery; TUMORS
- Publication
Cancer Chemotherapy & Pharmacology, 2015, Vol 75, Issue 1, p191
- ISSN
0344-5704
- Publication type
Article
- DOI
10.1007/s00280-014-2636-0