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

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careClosed25 and overNCI, OtherCDR0000553389
CALGB-170601, NCT00489411

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

National Cancer Institute

Ellen Lavoie SmithStudy Chair

Richard L. SchilskyPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00489411
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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