Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurotoxicity; Pain; Quality of Life
Intervention: gabapentin (Drug); quality-of-life assessment (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: North Central Cancer Treatment Group Official(s) and/or principal investigator(s):
Charles L. Loprinzi, MD, Study Chair, Affiliation: Mayo Clinic
Summary
RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral
neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy
in cancer patients undergoing chemotherapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating
pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.
Clinical Details
Official title: The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Study design: Supportive Care, Randomized, Double-Blind, Placebo Control
Detailed description:
OBJECTIVES:
- Determine whether gabapentin improves the pain and other symptoms in cancer patients
with chemotherapy-induced peripheral neuropathy.
- Determine the effect of this drug on symptom distress, mood states, functional
abilities, and overall quality of life in these patients.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to neurotoxic chemotherapy (active vs nonactive and discontinued vs
completed) and neurotoxic chemotherapeutic agents (vinca alkaloids vs taxanes vs
platinum-based compounds vs combination of two or more of the above agents). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive titrating doses of oral gabapentin twice daily and then three
times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three
times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8.
- Arm II: Patients receive titrating doses of oral placebo and then a fixed dose of oral
placebo as in arm I. Patients cross-over to therapy as in arm I at week 8.
Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Has received or is currently receiving neurotoxic chemotherapy, including taxanes
(e. g., paclitaxel or docetaxel), platinum-based compounds (e. g., carboplatin,
cisplatin, or oxaliplatin), or vinca alkaloids (e. g., vincristine or vinblastine)
- Pain or symptoms of peripheral neuropathy of at least 1 month duration attributed to
chemotherapy-induced peripheral neuropathy
- Average daily pain rating of at least 4 out of 10 using the pain numerical rating
scale (where 0 is no pain and 10 is the worst pain possible) OR
- Evidence of peripheral neuropathy of at least grade 1 out of 3 by ECOG Common
- Toxicity Criteria for sensory neuropathy
- No other identified causes of painful paresthesia existing prior to chemotherapy
- No radiotherapy-induced or malignant plexopathy
- No lumbar or cervical radiculopathy
- No pre-existing peripheral neuropathy of another etiology, including:
- B12 deficiency
- AIDS
- Monoclonal gammopathy
- Diabetes
- Heavy metal poisoning
- Amyloidosis
- Syphilis
- Hyperthyroidism or hypothyroidism
- Inherited neuropathy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- At least 6 months
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 1. 5 times upper limit of normal
Other:
- No prior allergic reaction or intolerance to gabapentin
- No significant psychiatric illness (e. g., mania, psychosis, or schizophrenia) that
would preclude study compliance
- No extreme difficulty swallowing pills
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Other:
- More than 30 days since prior investigational agent for pain control
- Concurrent selective serotonin reuptake inhibitors allowed
- Concurrent nonsteroidal anti-inflammatory drugs allowed
- No concurrent tricyclic antidepressant (e. g., amitriptyline, nortriptyline, or
desipramine)*
- No concurrent monoamine oxidase inhibitor*
- No concurrent opioid analgesic*
- No other concurrent adjuvant analgesic (e. g., anticonvulsant, clonazepam, or
mexiletine)*
- No concurrent topical analgesics (e. g., lidocaine gel or lidocaine patch)*
- No concurrent amifostine
- No concurrent investigational agent for pain control NOTE: * For pain or symptoms due
to chemotherapy-induced peripheral neuropathy
Locations and Contacts
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
Mayo Clinic, Jacksonville, Florida 32224, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States
Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Ochsner, New Orleans, Louisiana 70121, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States
CCOP - Duluth, Duluth, Minnesota 55805, United States
CentraCare Health Plaza, Saint Cloud, Minnesota 56303, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States
Altru Cancer Center, Grand Forks, North Dakota 58201, United States
Medcenter One Health System, Bismarck, North Dakota 58501-5505, United States
CCOP - Toledo Community Hospital, Toledo, Ohio 43623-3456, United States
CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States
Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, 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 2002
Last updated: May 23, 2008
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