Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gabapentin; gamma-Aminobutyric Acid

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

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