At a glance
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A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)
In Brief
A Phase 2 clinical trial evaluating Liposomal Irinotecan and FOLFOX regimen for Pancreatic Adenocarcinoma. Active but no longer recruiting, targeting 45 participants across 4 sites.
Detailed Summary
This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.
Study Details
Timeline
Interventions
Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.
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.