University of Florida/UF Health Cancer Center, Gainesville, FL;
Sherise C. Rogers , Ilyas Sahin , Jesus C. Fabregas , Ibrahim Nassour , Brian Hemendra Ramnaraign , Kathryn Hitchcock , Steven J. Hughes , Ji-Hyun Lee , Omar Roger Kayaleh , Anita Ahmed Turk , Z. Hugh Fan , Karen Bullock Russell , David L. DeRemer , Thomas J. George
Background: Neoadjuvant treatment for potentially curable pancreatic cancer (PDAC) is increasing in acceptability, but a standard regimen has yet to be established. Multiple studies have demonstrated feasibility and effectiveness of the FOLFIRINOX (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) regimen in the perioperative setting. However, FOLFIRINOX often requires dose modifications, delays and growth factor support due to excessive toxicity which can complicate care delivery when given neoadjuvantly. Liposomal irinotecan injection (Nal-IRI) is FDA approved with a well-tolerated safety profile in relapsed, refractory metastatic PDAC. The current study aims to substitute Nal-IRI for traditional irinotecan in the standard FOLFIRINOX regimen (NALIRIFOX) and to demonstrate safe and effective neoadjuvant delivery. Methods: This phase 2, open-label, multicenter single-arm study focuses on patients (pts) with operable PDAC without metastatic disease. Other key eligibility criteria include age ≥18 years, resectability confirmed by multidisciplinary GI tumor board (resectable vs. borderline), adequate cardiac, renal, hepatic function and ECOG performance status of 0 to 1. Pts receive NEO-N-IRI regimen as per Table every 2 weeks for four months followed by disease reassessment. Pts who remain surgical candidates will undergo surgical resection within 4 to 8 weeks following last dose of therapy. The primary endpoint is to assess safety and feasibility of regimen in perioperative setting. Secondary endpoints include R0 resection rate, clinical, biochemical and radiological response rate and patient-reported quality of life during treatment as measured by the NCI validated FACT-G scale. Enrollment continues to a maximum of 28 evaluable pts to demonstrate a reduction in historical 30-day postoperative complication rate. Microbiota specimens will be collected for exploratory analysis. Clinical trial information: NCT03483038.
Agent | Dose | Route/Duration |
---|---|---|
Nal-IRI | 50 mg/m2 | IV over 90 minutes |
Oxaliplatin | 60 mg/m2 | IV over 120 minutes |
Leucovorin | 400 mg/m2 | IV over 120 minutes |
5-fluorouracil infusion | 2400 mg/m2 | IV continuous infusion for 46 hours |
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Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Sherise C. Rogers
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Thomas J. George
2022 ASCO Annual Meeting
First Author: Sherise C. Rogers
2021 ASCO Annual Meeting
First Author: Sherise C. Rogers