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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00068445
First received: September 10, 2003
Last updated: July 7, 2015
Last verified: July 2015

September 10, 2003
July 7, 2015
February 2004
May 2006   (final data collection date for primary outcome measure)
Reduction of pain and symptoms of chemotherapy-induced peripheral neuropathy [ Time Frame: Up to 1 week post-treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00068445 on ClinicalTrials.gov Archive Site
Overall quality of life [ Time Frame: Up to 1 week post-treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Neurotoxicity
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: lamotrigine
  • Other: Placebo
  • Experimental: Arm I - lamotrigine

    Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks in the absence of unacceptable toxicity.

    Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks.

    Patients are followed at 3-7 days.

    Intervention: Drug: lamotrigine
  • Arm II - placebo

    Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks.

    Treatment continues for 10 weeks in the absence of unacceptable toxicity.

    Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks.

    Patients are followed at 3-7 days.

    Intervention: Other: Placebo
Renno SI, Rao RD, Sloan J, et al.: The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3. [Abstract] J Clin Oncol 24 (Suppl 18): A-8530, 475s, 2006.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
November 2013
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00068445
NCCTG-N01C3, CDR0000322830
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Ravi D. Rao, MD, MBBS Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP