Phase II Single Arm Clinical Trial of FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer
FOLFIRINOX regimen was recently presented at an international oncology meeting and
represents a new standard in the treatment of metastatic pancreatic cancer for selected
patients. With improved overall survival (OS) and response rates (RR) in the metastatic
setting, we hypothesize that in patients with less tumor burden, this regimen will be safe
and well tolerated, improve OS, progression free survival (PFS), and RR, and improve
resectability rates, as compared to historical data from standard single agent gemcitabine
therapy for unresectable locally advanced (ULA) patients and standard radiation with
concurrent 5 flourouracil (5FU) chemotherapy for borderline resectable (BR) patients. While
both ULA and BR patients will be eligible for the present study, our primary objective
concerns ULA patients, and we plan to enroll 45 patients in this group.
Patients meeting eligibility criteria will be consented and treated with FOLFIRINOX every 2
weeks (1 cycle = 4 weeks = 2 treatments). Patients will undergo repeat imaging (CT or MRI)
every 2 cycles and reassessed for resectability of the tumor. All patients that are not able
to undergo surgical resection, due to insufficient down-staging or patient preference, will
continue on protocol-based therapy until disease progression, unacceptable toxicity, study
withdrawal, or death.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median overall survival (OS) of FOLFIRINOX in patients with unresectable locally advanced (ULA) pancreatic cancer
All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).
Up to 3 years
No
Autumn J McRee, MD
Principal Investigator
University of North Carolina
United States: Institutional Review Board
LCCC 1105
NCT01688336
January 2012
February 2016
Name | Location |
---|---|
Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599-7305 |