Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Condition: Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: lamotrigine; Placebo
Intervention MeSH terms: Lamotrigine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neurotoxicity; pain; unspecified adult solid tumor, protocol specific

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:

        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