Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

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

Secondary

1. Determine the influence of this drug on peripheral neuropathy-related functional status and quality of life of these patients.
2. 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.

Entry 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)

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

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

Expected Enrollment

Outcomes

Average pain as measured by the BPI-SF

Peripheral neuropathy-related functional status
Quality of life as measured by FACT/COG-NTX and EORTC QLQ-C30 questionnaires in weeks 1, 6, 8, and 13

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Ellen Smith, PhD, ARNP, AOCN, Protocol chair		Ph: 734-936-1267
Richard Schilsky, MD, Principal investigator		Ph: 773-834-3914; 888-824-0200 Email: rschilsk@medicine.bsd.uchicago.edu

Registry Information
Official Title		A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Trial Start Date		2008-04-15
Trial Completion Date		2010-01-01 (estimated)
Registered in ClinicalTrials.gov		NCT00489411
Date Submitted to PDQ		2007-05-30
Information Last Verified		2011-03-03
NCI Grant/Contract Number		CA37447

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