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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Completed	over 18	NCI, Other	CDR0000065544 E1Z95, NCT00002996

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Charles F. Von Gunten

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00002996
Information obtained from ClinicalTrials.gov on January 27, 2010

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