Phase I Clinical Study of Three Times a Day Oral Administration of TAS-102 in Patients with Solid Tumors.
- Resource Type
- Article
- Authors
- Overman, Michael J.; Kopetz, Scott; Varadhachary, Gauri; Fukushima, Masakazu; Kuwata, Keizo; Mita, Akira; Wolff, Robert A.; Hoff, Paulo; Xiong, Henry; Abbruzzese, James L.
- Source
- Cancer Investigation. Dec2008, Vol. 26 Issue 8, p794-799. 6p. 3 Charts, 1 Graph.
- Subject
- *MEDICAL research
*PYRIMIDINE nucleotides
*THYMIDINE
*GRANULOCYTOPENIA
*PATIENTS
- Language
- ISSN
- 0735-7907
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. [ABSTRACT FROM AUTHOR]