Phase I Clinical Study of Three Times a Day Oral Administration of TAS-102 in Patients with Solid Tumors
- 1 January 2008
- journal article
- Published by Taylor & Francis Ltd in Cancer Investigation
- Vol. 26 (8), 794-799
- https://doi.org/10.1080/07357900802087242
Abstract
TAS-102 is a novel formulation of the fluorinated pyrimidine analogue trifluorothymidine (FTD) with an inhibitor of thymidine phosphorylase. The purpose of this study was to determine the MTD and DLT for TAS-102 administered three times a day on days 1–5 and 8–12 every 4 weeks. Fifteen patients were enrolled with two patients experiencing dose-limiting fatigue and granulocytopenia at the first dose level (80 mg/m2/day). Granulocytopenia was the primary toxicity: 7 patients experienced grade 3 or 4 granulocytopenia with the first course. No responses were noted, but nine patients demonstrated prolonged stable disease in this heavily pretreated 5-FU refractory population.Keywords
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