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FOR IMMEDIATE RELEASE: November 23, 2004
Contact: Karen Warmkessel kwarmkessel@umm.edu 410-328-8919
Ellen Beth Levitt eblevitt@umm.edu 410-328-8919

CLINICAL STUDY TESTS NEW CHEMOTHERAPY DRUG WITH RADIATION TO TREAT LOCALLY ADVANCED LUNG CANCER

UM Greenebaum Cancer Center is first to evaluate combination therapy with Velcade

Oncologists at the University of Maryland Greenebaum Cancer Center have started a Phase I clinical study to evaluate treatment with a new drug called Velcade, combined with standard chemotherapy and radiation, for patients with locally advanced non-small cell lung cancer.

Non-small cell lung cancer is the most common lung cancer, representing about 85 percent of more than 173,000 new cases diagnosed in the United States each year. In locally advanced, or Stage III cancer, the disease has spread beyond the lungs but is still confined to the chest and nearby lymph nodes. Patients with this stage of cancer are usually treated with radiation and chemotherapy, but some may also have surgery.

Velcade is the first in a new class of cancer-fighting agents known as proteasome inhibitors. Approved last year by the U.S. Food and Drug Administration for treatment of multiple myeloma, a bone marrow cancer, the drug blocks enzymes that play an important role in controlling the growth and survival of cells. Inhibiting these enzymes, called proteasomes, causes cancer cells to die.

“Velcade has been shown to boost the effectiveness of radiation in laboratory studies, but it has never been combined with radiation to treat patients with non-small cell lung cancer. We are the first institution to test this new combination therapy,” says Martin J. Edelman, M.D., director of medical thoracic oncology and the study’s principal investigator at the University of Maryland Greenebaum Cancer Center. Dr. Edelman is a medical oncologist specializing in thoracic oncology and new drug development. He is an associate professor of medicine at the University of Maryland School of Medicine.

He says that patients enrolled in the study will receive two standard chemotherapy drugs, paclitaxal and carboplatin, as well as radiation therapy and Velcade for six weeks. Then they will be evaluated to see if their tumors have shrunk sufficiently to be removed surgically. Patients who undergo surgery will also receive paclitaxal and carboplatin once every three weeks for two to three months afterward. Those who cannot have surgery will also receive chemotherapy.

“We know that combining chemotherapy and radiation can cure some people with lung cancer and the combination clearly improves survival rates compared with radiation or surgery alone. Chemotherapy and radiation, followed by surgery, may be an even better treatment option for certain patients,” Dr. Edelman says. “We want to find out if a newer agent, such as Velcade, can enhance the value of radiation or chemotherapy in treating this type of lung cancer.”

He says that lung cancer is often not diagnosed until the patients start having symptoms, such as a cough, shortness of breath, wheezing or chest pain. About 40 percent of patients have Stage III disease when they are diagnosed and another 40 percent have Stage IV, which means that the cancer has spread to other parts of the body. About 85 percent of patients with non-small cell lung cancer die of the disease.

“Lung cancer kills more patients each year than breast, colon and prostate cancer combined. It is by far the major cause of cancer death in the United States,” Dr. Edelman says.

He hopes to enroll 15 patients in the study, which will determine how well patients tolerate Velcade when it is given with the two other chemotherapy drugs and radiation. Investigators will also determine a safe dosage. The study was initiated by the University of Maryland Greenebaum Cancer Center and is supported by Millenium Pharmaceuticals, Inc., a Boston, Mass., company that manufactures Velcade.

Mohan Suntharalingam, M.D., a radiation oncologist at the University of Maryland Greenebaum Cancer Center and vice chairman and associate professor of radiation oncology at the University of Maryland School of Medicine, and King F. Kwong, M.D., a thoracic surgeon at the medical center and an assistant professor of surgery at the medical school, are co-investigators.

“This study builds on the University of Maryland’s expertise in the multi-modality treatment of non-small cell lung cancer,” Dr. Edelman says. Teams of medical oncologists, thoracic surgeons and radiation oncologists work together to evaluate patients and determine the best course of treatment.

Researchers at the cancer center are conducting more than a dozen clinical studies of possible new treatments for lung cancer, including new agents and chemotherapy drugs paired with radiation and surgery. Thoracic surgeons at the University of Maryland Medical Center have considerable experience in treating lung cancer and have developed techniques that have greatly reduced complications, Dr. Edelman says.

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