84
Participants
Start Date
September 11, 2016
Primary Completion Date
August 5, 2021
Study Completion Date
January 27, 2022
mFOLFIRINOX
"mFOLFIRINOX:~* Oxaliplatin 85 mg/m2 over 2-4 hours~* Irinotecan 165 mg/m2 over 90 minutes~* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia."
Ramucirumab
Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
Placebo
Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
Gettysburg Cancer Center, Gettysburg
Thomas Jefferson University Kimmel Cancer Center, Philadelphia
Emory University: Winship Cancer Institute, Atlanta
University of Louisville, James Graham Brown Cancer Center, Louisville
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
Community Healthcare System, Munster
Nebraska Methodist Hospital, Omaha
Mayo Clinic-Arizona, Scottsdale
Collaborators (1)
Eli Lilly and Company
INDUSTRY
Hoosier Cancer Research Network
OTHER
Walid Shaib, MD
OTHER