Celebrex Lung Cancer Trial Resumes
Researchers believe the controversial drug can help prevent malignancy
TUESDAY, July 12, 2005 (HealthDay News) -- A trial into whether the prescription anti-inflammatory drug Celebrex might help prevent lung cancer in former and current smokers has been reactivated by researchers at the University of Texas M.D. Anderson Cancer Center in Houston.
The center voluntarily halted the trial last December at the request of Pfizer, the maker of the drug, and the U.S. National Cancer Institute (NCI) until further data on the drug could be analyzed. A subsequent FDA review of the data confirmed concerns that Celebrex (celecoxib) increased long-term users' risk of heart attack and stroke.
However, advisors to the FDA also recommended that Celebrex continue to be studied in the treatment and prevention of cancer. The NCI supported the continuation of such trials.
M.D. Anderson then decided to reactivate the trial studying the effectiveness of Celebrex in preventing lung cancer in former and current smokers. New guidelines were introduced to the study to reduce risks to study participants, especially those with a history of hypertension or cardiovascular events.
The study participants' blood pressure and lipid counts will be closely monitored, and patients will receive aggressive treatment if there are any fluctuations in those areas. The patients will also be treated for only six months and individuals who've had heart attacks or strokes will not be allowed to take part in the trial.
"At this point, there is nothing available to deter lung cancer in smokers, even in those who have quit," principal investigator Dr. Jonathon M. Kurie, a professor in the department of thoracic/head and neck oncology, said in a prepared statement.
"In looking at the data, we believe the potential benefit to the patient is greater than the risk, and we have ample safeguards in place to monitor patients even more closely than they are now. We continue to believe this drug has potential to reduce the risk of lung cancer and that is a tremendous opportunity not to be overlooked," Kurie said.
The American Cancer Society outlines the risk factors for lung cancer.