Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Duloxetine Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer

• CNS malignancy allowed with the exception of leptomeningeal carcinomatosis

• Must have painful sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior treatment with single-agent taxane or platinum agents (paclitaxel, docetaxel, nab-paclitaxel, oxaliplatin, cisplatin) (may not have received drugs from both classes)

• CIPN > grade 1 as measured by NCI-CTCAE v 4.0

• Average neuropathic pain score ≥ 4

• Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses:

• Diabetes mellitus

• Peripheral vascular disease

• HIV infection

• Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy

• No clinical or subclinical neuropathy from nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression)

PATIENT CHARACTERISTICS:

• AST ≤ 3 times upper limit of normal

• Total bilirubin ≤ normal

• Creatinine clearance > 30 mL/min

• Not pregnant or nursing

• Able to take oral or enteral medication

• No history of seizure disorder

• No diagnosis of ethanol addiction or dependence within the past 10 years

• No history of narrow-angle glaucoma

• None of the following:

• History of suicidal thoughts

• Symptoms of or history of schizophrenia, bipolar disease, or a major depression

• Serious eating disorder such as bulimia or anorexia where electrolyte imbalance is likely

PRIOR CONCURRENT THERAPY:

• At least 3 months since prior and no concurrent taxane or platinum agent

• At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other antidepressants

• No other prior or concurrent neurotoxic drugs (e.g., vincristine, vinblastine, cytarabine, thalidomide, bortezomib, carboplatin, or procarbazine)

• No concurrent anticonvulsants

• No concurrent B or E vitamin supplementation in doses greater than the recommended daily allowance (RDA)

• Centrum (standard formula) and One-A-Day "essential" formula which contain 100% RDA for vitamins B6, E, and B12 allowed

• Other multivitamins allowed provided they contain no more than 100% RDA of B vitamins and vitamin E

• No concurrent treatment (pharmacologic) for depression