Aug. 6, 2001 Can a common anti-inflammatory drug help prevent lung cancer?
Researchers at UCLA’s Jonsson Cancer Center are seeking volunteers for two new research studies to find out.
For the first time, the studies will investigate whether the anti-inflammatory drug Celebrex has the potential to prevent lung cancer in people at high risk of developing the disease, which is expected to kill more than 157,000 American men and women this year.
One study involves lung cancer survivors who are at high risk of experiencing a recurrence or developing a new lung cancer. The other study involves individuals who smoke and are at high risk of developing lung cancer.
Celebrex, a non-steroidal pill used to treat arthritis and other inflammatory diseases, has been approved by the U.S. Food and Drug Administration for use in preventing colon cancer in a group of patients who are at particularly high risk for the disease. Laboratory investigations at UCLA since the mid-1990s have suggested that the drug may also prove effective in preventing lung cancer.
“This is the first time that Celebrex is being studied in humans for the purpose of preventing lung cancer,” said Dr. Jenny Mao, lead investigator for the study and a researcher at UCLA’s Jonsson Cancer Center.
The rationale for the studies is based on pre-clinical findings in the laboratory of Dr. Steven Dubinett, director of the UCLA Lung Cancer Research Program. The findings have shown that Celebrex can prevent lung cancer development and growth in mice, Mao said.
“We have detected changes in lung cancer cells at the molecular level that suggest a favorable response in terms of prevention. Celebrex is considered to be safer than aspirin, so Celebrex’s safety profile further enhances its promise as a preventive agent for lung cancer,” Mao said.
Lung cancer is the leading cause of cancer deaths among men and women in the United States. This year, 169,500 new cases will be diagnosed, according to the American Cancer Society.
“This means that more Americans will continue to die of lung cancer than colon, breast and prostate cancers combined,” said Mao, who also is an assistant professor, director of the Life-Lung Bronchoscopy Program and director of the Comprehensive Second-Lung Cancer Surveillance and Chemoprevention Program at the UCLA School of Medicine.
“Over the past decade, tremendous progress has been made in lung cancer research, both in diagnostic technology and in understanding tumor biology,” Mao said. “Although new diagnostic tests, including chest CT scans and fluorescence bronchoscopy, hold much promise for detecting lung cancer early enough to be cured by surgery, the ability of these methods to ultimately reduce lung cancer deaths still needs to be validated before they can be recommended for routine screening. Parallel to these advances in diagnostic technology, a better understanding of cancer biology has given rise to a new frontier in treatment called chemoprevention, which involves using drugs to prevent cancer development.
“Heavy smokers with chronic obstructive pulmonary disease (COPD) are at high risk of lung cancer. For patients whose early-stage lung cancers have been surgically removed, the risk of developing a new lung cancer increases by one to two percent every year. Developing effective chemopreventive strategies is particularly important for these groups,” Mao said.
The following are summaries of the new studies:
* A phase II study of Celebrex in 120 lung cancer patients who had stage I, non-small cell lung cancer that has been surgically removed. Through a randomized selection process, half of the study participants will receive Celebrex and half will receive placebo pills (an inactive substance). The purpose of this study is to determine whether patients will benefit from a comprehensive surveillance program alone or in combination with chemopreventive treatment with Celebrex. All participants will be monitored regularly for signs of pre-cancerous changes or early cancer development with fluorescence bronchoscopy and computerized tomography (CT) scans of the chest area. (Fluorescence bronchoscopy is powered by a special laser light source that significantly enhances the visibility of pre-cancerous changes in a patient’s air passages.) When used together, these diagnostic tools currently are believed to be the most effective comprehensive strategy to detect lung cancer early. Participants will be followed for two to five years.
* A six-month, phase II study of Celebrex in current smokers who are 45 or older, have smoked for a minimum of 20 “pack years” (the cumulative equivalent of a pack of cigarettes every day for 20 years), and who have mild COPD. This study is designed to identify cellular or molecular changes in the lungs that may indicate Celebrex’s impact on lung cancer development. Participants will receive free lung cancer screening with fluorescence bronchoscopy and up to $350 upon completing the study. Researchers are seeking 20 volunteers.
To be eligible for either study, participants must be in relatively good health, have no history of peptic ulcers and have no allergies to aspirin, ibuprofen or sulfa drugs. They also may be asked to stop taking certain medications that may interfere with Celebrex.
For more information on the studies, please call the Jonsson Cancer Center clinical trials hotline at 888-798-0719.
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