Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

September 11, 2016

Primary Completion Date

August 5, 2021

Study Completion Date

January 27, 2022

Conditions
Pancreatic Cancer
Interventions
DRUG

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."

DRUG

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.

OTHER

Placebo

Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.

Trial Locations (8)

17325

Gettysburg Cancer Center, Gettysburg

19107

Thomas Jefferson University Kimmel Cancer Center, Philadelphia

30322

Emory University: Winship Cancer Institute, Atlanta

40202

University of Louisville, James Graham Brown Cancer Center, Louisville

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

46321

Community Healthcare System, Munster

68114

Nebraska Methodist Hospital, Omaha

85259

Mayo Clinic-Arizona, Scottsdale

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

collaborator

Hoosier Cancer Research Network

OTHER

lead

Walid Shaib, MD

OTHER