Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: lamotrigine (Drug); Placebo (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Alliance for Clinical Trials in Oncology Official(s) and/or principal investigator(s): Ravi D. Rao, MD, MBBS, Study Chair, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Reduction of pain and symptoms of chemotherapy-induced peripheral neuropathy
Secondary outcome: Overall quality of life
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States
CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States
MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615-7828, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1854, United States
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center, Sioux City, Iowa 51101-1733, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
Coborn Cancer Center, Saint Cloud, Minnesota 56303, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States
Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota 58501-5505, United States
CCOP - Dayton, Dayton, Ohio 45429, United States
CCOP - Toledo Community Hospital, Toledo, Ohio 43623-3456, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 2004
Last updated: July 7, 2015
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