TAS102 in Combination With NAL-IRI in Advanced GI Cancers

Status Recruiting

Clinical Trial Summary

This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, 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 OBJECTIVES: I. Determine the recommended phase II dose for the combination of TAS-102 and nanoliposomal irinotecan (nanoliposomal [nal]-IRI). (Phase I) II. Evaluate the activity of the combination of TAS102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer. (Phase II) SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of TAS-102 and nal-IRI. II. Evaluate the response duration, progression free, and overall survival of the combination of TAS-102 and nal-IRI in previously treated patients with metastatic colorectal cancer and pancreatic cancer. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive nanoliposomal irinotecan intravenously (IV) over 90 minutes on day 1 and trifluridine/tipiracil hydrochloride combination agent TAS-102 orally (PO) twice daily (BID) on days 1-5. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 8 or 12 weeks thereafter. ;

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Cholangiocarcinoma
Colorectal Adenocarcinoma
Colorectal Neoplasms
Gastric Adenocarcinoma
Metastatic Pancreatic Adenocarcinoma
Non-Resectable Cholangiocarcinoma
Pancreatic Neoplasms
Stage III Colorectal Cancer
Stage III Gastric Cancer
Stage III Pancreatic Cancer
Stage IV Colorectal Cancer
Stage IV Gastric Cancer
Stage IV Pancreatic Cancer
Stage IVA Colorectal Cancer
Stage IVB Colorectal Cancer
Stomach Neoplasms
Unresectable Digestive System Adenocarcinoma
Unresectable Pancreatic Carcinoma

Clinical Trial Details

NCT number	NCT03368963
Study type	Interventional
Source	Emory University
Contact	Olatunji B. Alese, MD
Phone	404-778-2670
Email	olatunji.alese@emory.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	January 30, 2018
Completion date	November 28, 2025

View Details

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