Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
NCT ID: NCT00027963
Last Updated: 2016-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2002-02-28
2007-11-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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gabapentin
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.
Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
gabapentin
placebo
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.
placebo
Interventions
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gabapentin
placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Life expectancy:
* At least 6 months
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
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Charles L. Loprinzi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Health Plaza
Saint Cloud, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Medcenter One Health System
Bismarck, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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References
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Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer. 2007 Nov 1;110(9):2110-8. doi: 10.1002/cncr.23008.
Other Identifiers
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CDR0000069098
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-CCC-0020
Identifier Type: -
Identifier Source: secondary_id
NCI-P01-0196
Identifier Type: -
Identifier Source: secondary_id
NCCTG-N00C3
Identifier Type: -
Identifier Source: org_study_id
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