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

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

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.

Intervention(s) in this Clinical Trial

• Drug: gabapentin
• Procedure: quality-of-life assessment

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Central Cancer Treatment Group

Overall Clinical Trial Officials and Contacts

Charles L. Loprinzi, MD Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00027963

Study ID Number: CDR0000069098

ClinicalTrials.gov Identifier: NCT00027963

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database