Sylvester Comprehensive Cancer Center

UM/Sylvester Opens Clinical Trial of Blood Pressure Medication to Treat Side Effects in Lung Cancer

10.12.2004

Radiation oncologists at the University of Miami Sylvester Comprehensive Cancer Center have opened a phase II clinical trial of captopril (Capoten), an angiotensin converting enzyme inhibitor which is an established blood pressure medication. The controlled trial will test the drug’s ability to help patients with lung cancer, the world’s leading cause of cancer deaths. Captopril works by inhibiting the angiotensin II enzyme which causes blood vessels to constrict. This relaxes the blood vessels throughout the body, helping blood flow more efficiently.

“The drug has two purposes,” said David T. Huang, M.D., Ph.D., associate professor, Department of Radiation Oncology, UM/Sylvester. “One, it may reduce heart and lung damage from external beam radiation therapy, and two, it has anti-mitotic and anti-angiogenic effects that may slow cell division and the growth of new blood vessels to tumors.” Captopril may also improve quality of life for patients by preventing lung conditions like pulmonary fibrosis and pulmonary hypertension caused by radiotherapy.

“One of our restrictions with radiation therapy is that we have to limit the dose that we can deliver to the tumor so we don’t damage the heart and lungs,” said Huang. Radiotherapy can cause fibrosis scarring and blood vessel damage. “The protective nature of captopril will give us the ability to elevate the dose to the tumor but still be within a safe range for the heart and lungs. A higher dose has been shown, over and over, to improve tumor controls.”

The results will be compared to patients with the same diagnosis who are undergoing radiotherapy without taking captopril. “This is an established drug that has proven to be very safe in treating hypertension,” said Huang. “So we are anxious to learn whether we can use it to improve the outcome of patients with lung cancer.” And in many cases longtime smokers who present as lung cancer patients also have high blood pressure, making them excellent candidates for this trial.

Patients who are enrolled in the trial will be administered their first dose of captopril at UM/Sylvester, then be observed for two hours for signs of low blood pressure. “We want to monitor the patients for captopril’s potential hypotensive effect and make sure they take in adequate amount of food and fluids,” said Huang. If the first dose is tolerated well, the patient will receive a second dose the next day, with one hour of observation. Patients who respond as expected will begin taking captopril once a day on their own, with escalating doses, before and during radiation treatment.

“There are several medications that may play a role in cancer that weren’t intended as cancer treatments when they were developed,” said Huang. “Herceptin was developed as an antibiotic, for example, but has been very valuable in treating breast cancer. We hope captopril offers us a similar opportunity.”

This is a multi-center trial led by members of the Radiation Therapy Oncology Group. Several UM/Sylvester faculty members serve on research committees within the RTOG, which is composed of 250 leading research institutions, including UM. Investigators expect to enroll about 200 patients nationwide in the captopril study, which is one of five new clinical trials opening in Radiation Oncology at UM/Sylvester.

This year in the United States about 173,000 people will be diagnosed with lung cancer and 160,000 will die from the disease. Approximately 13,390 Floridians will be diagnosed with lung cancer this year and 12,360 are expected to die. Lung cancer is the leading cause of cancer deaths in the world, most often linked to smoking. Patients seeking additional information regarding this clinical trial should call (305) 243-1000.

UM/Sylvester was founded in 1992 to provide comprehensive cancer services and today serves as the hub for cancer-related research, diagnosis, and treatment at the University of Miami School of Medicine. UM/Sylvester handles more than 1,100 inpatient admissions annually, performs 2,800 surgical procedures, and treats 2,900 new cancer patients. All UM/Sylvester physicians are on the faculty of the University of Miami School of Medicine, South Florida’s only academic medical center. In addition, UM/Sylvester physicians and scientists are engaged in more than 150 clinical trials and receive more than $30 million annually in research grants. UM/Sylvester at Deerfield Beach recently opened to better meet the needs of residents of Broward and Palm Beach Counties. This 10,000 square-foot facility at I-95 and S.W. 10th Street offers appointments with physicians from six cancer specialties, complementary therapies from the Courtelis Center, and education and outreach events.

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