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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Topical Eflornithine Hydrochloride Ointment Alone Versus Topical Diclofenac Sodium Gel Alone Versus Topical Eflornithine Hydrochloride Ointment Combined With Topical Diclofenac Sodium Gel in Patients With Sun-Damaged Skin

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Prevention Active 40 and over NCI UARIZ-BIO-06182 BIO #06-182, NCT00601640

Trial Description

Purpose:

Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin.

This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.

Eligibility:

Eligibility criteria include the following:

• At least 40 years old
• No skin inflammation on the forearms
• No actinic keratoses in the area to be treated
• More than 6 months since chemotherapy
• More than 2 months since diclofenac taken by mouth or intravenous eflornithine
• More than 1 month since topical retinoids, steroids, imiquimod, aminolevulinic acid, eflornithine, diclofenac, or fluorouracil
• More than 1 month since topical medication on the left forearm
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of three treatment groups.

Patients in group one will apply topical eflornithine to their left arm twice a day for 3 months.

Patients in group two will apply topical diclofenac to their left arm once a day for 3 months.

Patients in group three will apply topical eflornithine twice a day and topical diclofenac to their left arm once a day for 3 months.

Before beginning treatment and 2-3 weeks after finishing treatment, patients will undergo three punch biopsies taken from the skin of the left arm for laboratory studies. Blood samples will also be collected.

Photographs will be taken of sun-damaged skin at the beginning of the study and within 2 weeks after finishing treatment.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Arizona Cancer Center at University of Arizona Health Sciences Center

Joanne Jeter, MD, Principal investigator		Ph: 520-626-9293; 800-622-2673 Email: jjeter@azcc.arizona.edu

U.S.A.
Arizona
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008

Registry Information
Official Title		Phase IIB Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine and Topical Diclofenac in the Treatment of Sun-Damaged Skin on the Forearm
Trial Start Date		2007-01-16
Trial Completion Date		2009-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00601640
Date Submitted to PDQ		2008-01-07
Information Last Verified		2008-10-17
NCI Grant/Contract Number		CA027502, CA23074