TAS102 and Liposomal Irinotecan in Treating Patients with Gastrointestinal Cancers That Are Locally Advanced, Metastatic, or Cannot Be Removed by Surgery

Active:	Yes
Cancer Type:	Bile Duct Cancer	NCT ID:	NCT03368963
Trial Phases:	Phase I Phase II	Protocol IDs:	Winship4146-17 (primary) NCI-2017-01661 IRB00098958
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03368963

Summary

This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and liposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to nearby tissue and lymph nodes (locally advanced), 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 liposomal 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.

Objectives

PRIMARY OBJECTIVES:
I. Determine the recommended phase II dose for the combination of TAS-102 and liposomal 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 activity 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 liposomal 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.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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