NCT00489411

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

Official Title:

A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

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.

Eligibility

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

Disease(s) and\or Condition(s)

Neurotoxicity

Pain

Peripheral Neuropathy

Unspecified Adult Solid Tumor, Protocol Specific

Primary Purpose
  • SUPPORTIVE_CARE
Intervention/Treatment
    • Type: DRUG
    • Name: duloxetine hydrochloride
    • Description: Given orally
    • Arm Group Labels: Arm I/Group A (Duloxetine then Placebo), Arm II/Group B (Placebo then Duloxetine)
    • Type: OTHER
    • Name: placebo
    • Description: Given orally
    • Arm Group Labels: Arm I/Group A (Duloxetine then Placebo), Arm II/Group B (Placebo then Duloxetine)
Sponsor
  • Alliance for Clinical Trials in Oncology