Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

Conditions
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Neurotoxicity, Pain

Intervention / Treatment
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* Drug: gabapentin
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gabapentin<br>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. | Drug: gabapentin<br> <br> |
| Placebo Comparator: placebo<br>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. | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain and symptoms |  | Up to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | Up to 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurotoxicity, pain