Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Last updated: April 3, 2018
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Pain

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00068445
NCCTG-N01C3
CDR0000322830
  • Ages > 18
  • All Genders

Study Summary

RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy in patients with cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer

  • Received, or are currently receiving, neurotoxic chemotherapy, including any of the following:

  • Taxanes (e.g., paclitaxel or docetaxel)

  • Platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin)

  • Vinca alkaloids (e.g., vincristine or vinblastine)

  • Experiencing pain or symptoms of peripheral neuropathy for at least 1 month attributed to chemotherapy

  • Average daily pain rating of at least 4 out of 10 OR

  • Peripheral neuropathy at least grade 1 out of 3 using ECOG sensory neuropathy rating

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Life expectancy

  • At least 6 months

Hepatic

  • Bilirubin < 2 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • No prior allergic reaction or intolerance to lamotrigine

  • No extreme difficulty swallowing pills

  • No other identified causes of painful paresthesia preceding chemotherapy, including any of the following:

  • Radiation or malignant plexopathy

  • Lumbar or cervical radiculopathy

  • Pre-existing peripheral neuropathy of another etiology, such as any of the following:

  • Cyanocobalamin deficiency

  • AIDS

  • Monoclonal gammopathy

  • Diabetes

  • Heavy metal poisoning amyloidosis

  • Syphilis

  • Hyperthyroidism or hypothyroidism

  • Inherited neuropathy

  • No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study participation

  • Able to complete questionnaires

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • See Disease Characteristics

  • More than 7 days since prior methotrexate or other dihydrofolate inhibitors

Other

  • More than 7 days since prior, and no concurrent use of any of the following:

  • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, or desipramine)

  • Concurrent selective serotonin reuptake inhibitors allowed

  • Monoamine oxidase inhibitors

  • Opioid analgesics

  • Anticonvulsants (e.g., gabapentin, topiramate, valproic acid, or clonazepam)

  • Adjuvant analgesics (e.g., mexiletine)

  • Prior nonsteroidal anti-inflammatory drugs allowed

  • Topical analgesics (e.g., lidocaine gel or patch) to the affected area

  • Amifostine

  • More than 30 days since prior investigational agents for pain control

  • No other concurrent investigational agents for pain control

Study Design

Total Participants: 131
Study Start date:
February 01, 2004
Estimated Completion Date:
November 30, 2013

Study Description

OBJECTIVES:

  • Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer.

  • Compare symptom distress, mood states, functional abilities, and overall quality of life of patients treated with these agents.

  • Determine the toxic effects of lamotrigine in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to neurotoxic chemotherapy received (taxanes vs platinum-based compounds vs vinca alkaloids vs combination vs other), status of neurotoxic chemotherapy (actively receiving therapy vs discontinued or completed), and duration of pain or neuropathy symptoms (1-3 months vs 3-6 months vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.

Connect with a study center

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • CCOP - Atlanta Regional

    Atlanta, Georgia 30342-1701
    United States

    Site Not Available

  • MBCCOP - Hawaii

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615-7828
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa 52403-1206
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 50309-1854
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center

    Sioux City, Iowa 51101-1733
    United States

    Site Not Available

  • CCOP - Wichita

    Wichita, Kansas 67214-3882
    United States

    Site Not Available

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Coborn Cancer Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska 68106
    United States

    Site Not Available

  • Cancer Care Center at Medcenter One Hospital

    Bismarck, North Dakota 58501-5505
    United States

    Site Not Available

  • CCOP - Dayton

    Dayton, Ohio 45429
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital

    Toledo, Ohio 43623-3456
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Rapid City Regional Hospital

    Rapid City, South Dakota 57709
    United States

    Site Not Available

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.