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

Inclusion 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