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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03254394.
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 1 and 2 years.
Trial PhasePhase I/II
Trial Typesupportive care
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorSimon Haroutounian
