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The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial

Phase 3
18 Years
Open (Enrolling)
Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial


- 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.

- 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

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.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this

Inclusion Criteria


- Diagnosis of cancer

- Received, or are currently receiving, neurotoxic chemotherapy, including any of the

- 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



- 18 and over

Performance status

- Not specified

Life expectancy

- At least 6 months


- Not specified


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


- Creatinine ≤ 1.5 times ULN


- 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

- Cyanocobalamin deficiency


- 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


Biologic therapy

- Not specified


- See Disease Characteristics

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

Endocrine therapy

- Not specified


- Not specified


- Not specified


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Ravi D. Rao, MD, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Neurotoxicity
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • neurotoxicity
  • pain
  • unspecified adult solid tumor, protocol specific
  • Peripheral Nervous System Diseases
  • Neurotoxicity Syndromes



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