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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
N/A
Open (Enrolling)
Both
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


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.

- 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.

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

Inclusion 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

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

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

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000322830

NCT ID:

NCT00068445

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

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - DaytonKettering, Ohio  45429
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Coborn Cancer CenterSaint Cloud, Minnesota  56303
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer CenterSioux City, Iowa  51101