Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

OBJECTIVES:

Primary

• Determine the efficacy of duloxetine hydrochloride in cancer patients with painful chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.

Secondary

• Determine the influence of this drug on peripheral neuropathy-related functional status and quality of life of these patients.

• Describe the differences in duloxetine hydrochloride efficacy when used to treat pain caused by chemotherapy-induced peripheral neuropathy based on the neurotoxic drug and class.

OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients are stratified according to prior neurotoxic agent (paclitaxel vs oxaliplatin vs other taxane agents without paclitaxel vs platinum agents [cisplatin] without oxaliplatin) and high risk for developing painful chemotherapy-induced peripheral neuropathy (no vs yes). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.

• Arm II: Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.

Patients complete pain and quality of life questionnaires, including the BPI-SF once weekly and FACT/GOG-NTX and EORTC QLQ-C30 questionnaires, in weeks 1, 6, 8, and 13.

After completion of study treatment, patients are followed for 2 weeks.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Ellen Lavoie Smith

Study Chair

Richard L. Schilsky

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00489411
Information obtained from ClinicalTrials.gov on February 13, 2013

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