NCI Cancer Bulletin: A Trusted Source for Cancer Research NewsNCI Cancer Bulletin: A Trusted Source for Cancer Research News
May 25, 2004 • Volume 1 / Number 21 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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Featured Clinical TrialFeatured Clinical Trial

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 at

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

Why Is This Trial 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 nonmelanoma skin cancers, tumors that develop in the uppermost layer of the skin). Roughly one out of six have squamous cell cancer, a type of nonmelanoma skin cancer. Although nonmelanoma 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.

Who Can Join This Trial?
Researchers want to enroll 240 patients aged 18 and older with at least 10 AKs on the arms, head, or neck. See the full list of eligibility criteria for this trial at

Where Is This Trial Taking Place?
Multiple study sites in the United States are enrolling patients in this trial. See the list of study sites at

Who to Contact
See the list of study contacts at, 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.

An archive of "Featured Clinical Trial" columns is available at