26
Participants
Start Date
September 15, 2017
Primary Completion Date
September 28, 2020
Study Completion Date
April 1, 2021
Lidocaine Hydrochloride
"Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.~If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study."
Placebo
Dextrose 5% in water will be administered as active comparator.
FOLFOX regimen
"Each cycle (repeated every 14 days):~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
Washington University School of Medicine/Barnes Jewish Hospital, St Louis
Washington University School of Medicine
OTHER