Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	NCCTG-N01C3 N01C3, NCT00068445

Objectives

1. Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer.
2. Compare symptom distress, mood states, functional abilities, and overall quality of life of patients treated with these agents.
3. Determine the toxic effects of lamotrigine in these patients.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

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

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

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

Expected Enrollment

A total of 120 patients (60 per treatment arm) will be accrued for this study.

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.

• Arm I: Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks.
• Arm II: Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks.

In both arms, 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.

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Ravi Rao, MD, MBBS, Protocol chair		Ph: 507-284-2511
Charles Loprinzi, MD, Protocol co-chair		Ph: 507-284-2511 Email: cloprinzi@mayo.edu

Registry Information
Official Title		The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
Trial Start Date		2004-02-13
Registered in ClinicalTrials.gov		NCT00068445
Date Submitted to PDQ		2003-07-18
Information Last Verified		2004-09-03

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