Phase I clinical study of three times a day oral administration of TAS-102 in patients with solid tumors.
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.
Overman, MJ; Kopetz, S; Varadhachary, G; Fukushima, M; Kuwata, K; Mita, A; Wolff, RA; Hoff, P; Xiong, H; Abbruzzese, JL
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