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Clinical Trial Summary

Using alternative neoadjuvant gemcitabine-nab-paclitaxel and nal-IRI with 5-Fluorouracil (5FU) and folinic acid (Leucovorin) regimens of localized cancer, we hope to ensure exposure of the cancer to a broader array of potentially active agents. Also, potentially improves patient tolerance and minimizes significant drug toxicity that could impair delivery of all treatment elements. Furthermore, it may enable prediction of superior to inferior treatment outcomes at an earlier point in the disease progress.


Clinical Trial Description

This research study is a Phase Ib clinical trial. It will assess the Safety, tolerability, and feasibility of gemcitabine-nab paclitaxel alternating with nal-IRI/5FU/leucovorin (NAPOLI) in de novo resectable and borderline resectable pancreatic cancer. Subjects must have a newly diagnosed resectable or borderline resectable pancreatic ductal cancer and meet all inclusion/exclusion criteria. Treatment consists of 4 week treatment cycles. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15 with NAPOLI will be administered on days 1 and 15. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03703063
Study type Interventional
Source Benaroya Research Institute
Contact Vincent J Picozzi, MD
Phone 206-223-6193
Email Vincent.Picozzi@virginiamason.org
Status Recruiting
Phase Phase 1
Start date September 17, 2018
Completion date September 17, 2022

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