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Sponsors and Collaborators: |
University of Arizona National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601640 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
Non-Melanomatous Skin Cancer |
Drug: diclofenac sodium gel Drug: eflornithine hydrochloride ointment |
Phase II |
MedlinePlus related topics: | Cancer Skin Cancer |
Drug Information available for: | Eflornithine Diclofenac Diclofenac potassium Diclofenac sodium |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
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 |
Estimated Enrollment: | 138 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I: Experimental
Patients apply topical eflornithine hydrochloride ointment to their left forearm twice daily on days 1-90.
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Drug: eflornithine hydrochloride ointment
Given topically twice daily on days 1-90
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Arm II: Active Comparator
Patients apply topical diclofenac sodium gel to their left forearm once daily on days 1-90.
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Drug: diclofenac sodium gel
Given topically twice daily on days 1-90
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Arm III: Experimental
Patients apply topical eflornithine hydrochloride ointment as in arm I twice daily and topical diclofenac sodium gel as in arm II once daily on days 1-90.
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Drug: diclofenac sodium gel
Given topically twice daily on days 1-90
Drug: eflornithine hydrochloride ointment
Given topically twice daily on days 1-90
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OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
Prior to treatment, three 4-mm punch biopsies are taken from the skin of the left lateral forearm for assessment of histopathology, the cyclooxygenase-2 enzyme and p53 expression, apoptosis, and nuclear chromatin karyometry. Tissue is also obtained for future use in microarray analysis. Blood is drawn for assessment of ornithine decarboxylase polymorphisms and for banking for subsequent studies. Biopsies are repeated 2-3 weeks after completion of treatment.
Digital photographs are taken at baseline and 1-2 weeks after completion of study therapy to document improvement of sun damage, appearance of new skin lesions, and toxicity.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Resident of Pima or an adjoining Southern Arizona county
PATIENT CHARACTERISTICS:
History of treated basal cell carcinoma and/or squamous cell carcinoma of the skin at any site other than the left forearm allowed if excision or topical treatment was completed more than 30 days ago (60 days for radiotherapy)
PRIOR CONCURRENT THERAPY:
No concurrent non-steroidal anti-inflammatory drugs (NSAIDs) for more than 14 days per month for arthritic and other pain conditions
United States, Arizona | |||||
Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting | ||||
Tucson, Arizona, United States, 85724-5024 | |||||
Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 |
University of Arizona |
National Cancer Institute (NCI) |
Principal Investigator: | Joanne M. Jeter, MD | University of Arizona |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000581429, UARIZ-BIO-06182 |
First Received: | January 22, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00601640 |
Health Authority: | Unspecified |
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