Flecainide in Treating Patients With Chronic Neuropathic Pain
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: flecainide acetate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Eastern Cooperative Oncology Group Official(s) and/or principal investigator(s):
Charles F. Von Gunten, MD, PhD, Study Chair, Affiliation: Robert H. Lurie Cancer Center
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.
Clinical Details
Official title: Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial
Study design: Supportive Care
Detailed 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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-0001, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: February 1998
Last updated: May 29, 2008
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