NCT03483038View on ClinicalTrials.gov

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

December 13, 2018

Primary Completion Date

September 16, 2023

Study Completion Date

February 28, 2026

Conditions
Pancreatic Adenocarcinoma
Interventions
DRUG

Liposomal Irinotecan

Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.

DRUG

FOLFOX regimen

Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.

Trial Locations (4)

32308

Tallahassee Memorial Health Care, Tallahassee

32608

University of Florida, Gainesville

32806

Orlando Health UF Health Cancer Center, Orlando

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

Sponsors

Collaborators (1)

Ipsen
All Listed Sponsors
collaborator

Ipsen

INDUSTRY

lead

University of Florida

OTHER