Lidocaine for Oxaliplatin-induced Neuropathy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 15, 2017

Primary Completion Date

September 28, 2020

Study Completion Date

April 1, 2021

Conditions
Neuropathy, PainfulChemotherapy-induced Peripheral NeuropathyColorectal Cancer
Interventions
DRUG

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."

DRUG

Placebo

Dextrose 5% in water will be administered as active comparator.

DRUG

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."

Trial Locations (1)

63110

Washington University School of Medicine/Barnes Jewish Hospital, St Louis

All Listed Sponsors
lead

Washington University School of Medicine

OTHER

NCT03254394 - Lidocaine for Oxaliplatin-induced Neuropathy | Biotech Hunter | Biotech Hunter