Phase I Clinical Study of Three Times a Day Oral Administration of TAS-102 in Patients with Solid Tumors

Author: Overman Michael   Kopetz Scott   Varadhachary Gauri   Fukushima Masakazu   Kuwata Keizo   Mita Akira   Wolff Robert   Hoff Paulo   Xiong Henry   Abbruzzese James  

Publisher: Informa Healthcare

ISSN: 0735-7907

Source: Cancer Investigation, Vol.26, Iss.8, 2008-10, pp. : 794-799

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Previous Menu Next

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.

Related content