NCT04294264

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Carcinoma
• Recurrent Colon Carcinoma
• Refractory Colorectal Carcinoma
• Stage IV Colon Cancer AJCC v7
• Stage IVA Colon Cancer AJCC v7
• Stage IVB Colon Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Given IV
DRUG	Trifluridine and Tipiracil Hydrochloride	Given PO

Timeline

• Start date: 2019-02-12
• Primary completion: 2024-03-27
• Completion: 2026-03-27
• First posted: 2020-03-04
• Last updated: 2024-11-18

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study