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A Phase I / II Study of Trifluridine / Tipiracil (TAS102) in Combination with Nanoliposomal Irinotecan (NAL-IRI) in Advanced GI Cancers

Status
Active
Cancer Type
Pancreatic Cancer
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03368963
Protocol IDs
Winship4146-17 (primary)
NCI-2017-01661
IRB00098958
Study Sponsor
Emory University Hospital / Winship Cancer Institute

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 has spread to other places in the body 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. Courses 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.
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