TAS-102 Combined with Alternating Oxaliplatin and Irinotecan (Sequential TASOXIRI) with or without Bevacizumab for the Treatment of Refractory and Metastatic Colorectal Cancer
This phase II trial tests how well trifluridine and tipiracil hydrochloride (TAS-102) in combination with alternating oxaliplatin and irinotecan (sequential TASOXIRI) with or without bevacizumab works in treating patients with colorectal cancer that does not respond to treatment (refractory) and has spread from where it first started (primary site) to other places in the body (metastatic). TAS-102 is a combination of trifluridine and tipiracil hydrochloride. Trifluridine is in a class of medications called thymidine-based nucleoside analogues. It works by stopping the growth of tumor cells. Tipiracil is in a class of medications called thymidine phosphorylase inhibitors. It works by slowing the breakdown of trifluridine by the body to help trifluridine work longer. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell’s deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Sequential TASOXIRI with or with bevacizumab may increase response rates beyond that expected of TAS-102 and oxaliplatin alone, while also maintaining acceptable tolerability for patients with refractory or metastatic colorectal cancer.