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Skin Cancer Prevention Study

Name of the Trial

Phase II/III Randomized Chemoprevention Study of Celecoxib in Patients with Actinic Keratoses. See the protocol summary.

Principal Investigator

Dr. Craig Elmets, University of Alabama at Birmingham Comprehensive Cancer Center.

Dr. Craig Elmets

Dr. Craig Elmets
Principal Investigator

Why This Trial Is Important

Skin cancer is the most common cancer, accounting for at least half of all cancer diagnoses. More than a million people are diagnosed with skin cancer every year in the United States (most are diagnosed with non-melanoma skin cancers, tumors that develop in the uppermost layer of the skin). Roughly one out of six have squamous cell cancer, a type of non-melanoma skin cancer. Although non-melanoma skin cancers rarely metastasize and are curable if detected and treated early, squamous cell cancer can grow quickly and can be locally destructive.

Actinic keratoses (AKs) are precancerous skin growths that are usually caused by sun exposure, typically in fair-skinned people. They begin as rough, scaly patches or bumps on the skin and later develop into hard, wart-like growths. Untreated, about one in 10 AKs is likely to develop into squamous cell cancer.

Findings from animal studies suggest that the drug celecoxib (Celebrex®) may prevent the development of squamous cell cancer, said Dr. Elmets. Celecoxib blocks an enzyme called cyclooxygenase-2 (COX-2). Levels of COX-2 are elevated in AKs and squamous cell cancer but not in normal skin. "Moreover, animals deficient in COX-2 have a reduced incidence of skin cancer, and mice given celecoxib also have a lower incidence of skin cancer," added Dr. Elmets.

The study seeks to determine if celecoxib prevents new AKs from developing, causes existing AKs to go away, and prevents AKs from progressing to squamous cell cancer.

Contact Information

This study is no longer recruiting new patients. To locate other skin cancer clinical trials, search the NCI's database of clinical trials or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll-free and completely confidential.

  • Posted: May 25, 2004