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TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer

Metastatic Colorectal Carcinoma Clinical Trial

Official title:
TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer

Clinical Trial Summary

This phase II trial studies how well TAS-102 and oxaliplatin work in treating patients with stage IV colon cancer. Drugs used in chemotherapy, such as TAS-102 and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Overall response rate (ORR). SECONDARY OBJECTIVES: I. Progression free survival (PFS). II. Overall survival (OS). III. Disease control rate (DCR). IV. Duration of response. V. Safety and tolerability. OUTLINE: Patients receive trifluridine and tipiracil hydrochloride (TAS-102) orally (PO) twice daily (BID) on days 1-5 and oxaliplatin intravenously (IV) over 2 hours on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04294264
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 12, 2019
Completion date March 31, 2024
View Details
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