Flecainide in Treating Patients With Chronic Neuropathic Pain

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: flecainide acetate

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00002996

CDR0000065544

E1Z95

Details and patient eligibility

About

RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.

PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.

Full description

OBJECTIVES:

• Investigate the effectiveness of flecainide in the management of neuropathic pain.

OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon enrollment in the study. Following a 7 day stabilization period, flecainide is administered. One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are completed on days 8, 15 and 22 to assess neuropathic pain.

PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.

Enrollment: 20 estimated patients

Sex: All

Ages: 19 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Chronic neuropathic pain with diagnosis of cancer or AIDS

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• SGOT no greater than 2 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 2 times ULN

Cardiovascular:

• No clinical history of infarction or angina
• No advanced heart failure
• No sick sinus syndrome, intraventricular conduction disease, second or third degree AV block or arrhythmias requiring treatment (exception may be granted by cardiac consult)
• No focal wall motion abnormalities
• Ejection fraction at least 40%
• Systolic blood pressure at least 90 mm Hg

Other:

• Must be able to take oral medication
• No known allergy or adverse reaction to flecainide, mexilitene or any other type I antiarrhythmic drug
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 2 weeks since prior chemotherapy that may cause neuropathy

Endocrine therapy:

• At least 2 weeks since prior corticosteroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No tricyclic antidepressant treatment within past 2 weeks
• No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug