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Brief Title: TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
Official Title: TAS-102 in Combination With Oxaliplatin (TAS-OX) for Refractory Metastatic Colorectal Cancer
Study ID: NCT04294264
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Trinitas Hospital and Comprehensive Cancer Center, Elizabeth, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus, Lakewood, New Jersey, United States
Saint Barnabas Medical Center, Livingston, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center, Long Branch, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
RWJBarnabas Health - Community Medical Center, Toms River, New Jersey, United States
Name: Howard S Hochster
Affiliation: Rutgers Cancer Institute of New Jersey
Role: PRINCIPAL_INVESTIGATOR