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.
Publication types
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Clinical Trial, Phase I
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Research Support, Non-U.S. Gov't
MeSH terms
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Adenocarcinoma / drug therapy
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Administration, Oral
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Adult
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Aged
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Antimetabolites, Antineoplastic / administration & dosage*
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Antimetabolites, Antineoplastic / adverse effects
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Antimetabolites, Antineoplastic / therapeutic use
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Colorectal Neoplasms / drug therapy
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Disease-Free Survival
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Dose-Response Relationship, Drug
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Drug Administration Schedule
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Drug Combinations
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Female
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Gastrointestinal Diseases / chemically induced
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Hematologic Diseases / chemically induced
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Humans
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Male
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Maximum Tolerated Dose
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Middle Aged
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Neoplasms / drug therapy*
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Pyrrolidines
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Thymine
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Trifluridine / administration & dosage*
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Trifluridine / adverse effects
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Trifluridine / therapeutic use
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Uracil / administration & dosage
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Uracil / adverse effects
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Uracil / analogs & derivatives*
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Uracil / therapeutic use
Substances
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Antimetabolites, Antineoplastic
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Drug Combinations
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Pyrrolidines
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trifluridine tipiracil drug combination
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Uracil
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Thymine
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Trifluridine