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Lidocaine Hydrochloride in Preventing Oxaliplatin-Induced Peripheral Neuropathy in Patients with Stage III-IV Colorectal Cancer

Trial Status: Active

This randomized phase I / II trial studies the best dose and side effects of lidocaine hydrochloride and how well it works in preventing oxaliplatin-induced peripheral neuropathy in patients with stage III-IV colorectal cancer. Lidocaine hydrochloride may work by blocking the nerve damaging effects of oxaliplatin.

Inclusion Criteria

  • Diagnosed with stage III or IV colorectal cancer
  • Scheduled for oxaliplatin treatment in modified leucovorin calcium, fluorouracil and oxaliplatin regimen (mFOLFOX)6-based chemotherapy regimen
  • Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria

  • Renal insufficiency (defined as calculated creatinine clearance < 30 mL/min)
  • Moderate to severe liver failure (defined as alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times upper limit of normal if no liver metastases are present; ALT or AST > 5 times upper limit of normal if liver metastases are present)
  • Presence of brain metastases
  • Patients with currently uncontrolled cardiac arrhythmias (non-sinus rhythm) will be excluded; patients with history of arrhythmias under pharmacological/pacemaker control will be allowed, except if receiving antiarrhythmic medication listed in “contra-indicated medications” below
  • Contraindication or allergy to intravenous lidocaine
  • Pre-existing symmetric peripheral painful neuropathy
  • Treated with chemotherapy within the past 12 months
  • Pregnant and/or breastfeeding; women of childbearing potential must have a negative pregnancy test within 14 days of study entry
  • Currently treated with any of the following contraindicated medications: * Saquinavir, Lopinavir, Amprenavir, Atazanavir, Delavirdine * Mexiletine (and other types of sodium-channel blocker antiarrhythmics) * Phenytoin, Carbamazepine, Oxcarbazepine, Lamotrigine * Amiodarone * Dronedarone * Dihydroergotamine * Cimetidine

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
Contact: Simon Haroutounian
Phone: 314-286-1715

PRIMARY OBJECTIVES:

I. To determine the tolerability (defined as lack of dose-limiting toxicity) of lidocaine hydrochloride (lidocaine) co-infusion in colorectal cancer patients treated with oxaliplatin.

II. To determine the initial efficacy of intravenous lidocaine as a systemic voltage-gated sodium channel (Nav) blocker in preventing oxaliplatin-induced peripheral neuropathy.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive lidocaine hydrochloride intravenously (IV) over 130 minutes, oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo IV over 130 minutes, oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, fluorouracil IV continuously on days 1 and 2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 weeks, 8-10 weeks, and then at 2 years.

Trial Phase Phase I/II

Trial Type Supportive care

Lead Organization
Siteman Cancer Center at Washington University

Principal Investigator
Simon Haroutounian

  • Primary ID 201705166
  • Secondary IDs NCI-2017-01481
  • Clinicaltrials.gov ID NCT03254394