Clinical trials pave the way for medical advances
Feb. 8, 2013
By Doug Boyd
ECU News Services
Like many patients at the Leo W. Jenkins Cancer Center, Mary Jones drives to Greenville for regular follow-up visits with an oncologist.
But what makes Jones different is that she's participating in a clinical trial. Her experience, and those of thousands of other patients across the country, could lead to better cancer care for future patients.
Two years ago, Jones, visited her primary care physicians after feeling nauseous for a couple of days. He quickly referred her to specialists in Greenville. When she arrived at the medical center, she immediately underwent a series of tests that confirmed the worst: A CT scan showed Jones, who was 71 at the time, had a mass on her pancreas, a deadly diagnosis.
East Carolina University surgeon Dr. Timothy Fitzgerald recommended surgery as soon as possible – once Jones' blocked bile duct opened enough to drain the buildup of digestive fluid. And Jones didn't hesitate to agree to the operation.
"He told me before surgery it was very, very serious and the high percentage of patients who don't make it through the surgery," said Jones, a retired school cafeteria manager from Roper.
But Fitzgerald added that Jones was in otherwise good health, which increased her chances. "That gave me hope there," she said.
He also told her of a clinical trial under way at ECU to study the effectiveness of a certain combination of cancer drugs for people who had undergone surgery for pancreatic cancer. Jones agreed to participate.
The Brody School of Medicine at ECU is part of a national multi-center clinical trial investigating chemotherapy strategies for patients with certain kinds of pancreatic cancer. At ECU, the principal investigator is Dr. Clinton Leinweber, a clinical professor of radiation oncology.
Patients with pancreatic cancer that has been surgically removed usually receive chemotherapy plus radiation therapy. In this study, researchers want to see if giving one chemotherapy drug without radiation is equivalent to the same chemotherapy drug with radiation.
They also want to study the potential benefits of adding a second drug to the chemotherapy regimen after surgery. Five months later, if there is no evidence of disease recurrence, in the last phase of the study, patients are randomly assigned to receive an additional cycle of chemotherapy with or without radiation therapy. Jones was assigned to the group that received chemotherapy drugs and radiation.
Physicians at the Brody School of Medicine at ECU develop, conduct and lead clinical trials as a way to provide their patients with the best range of advanced treatment options. ECU spends nearly $2 million annually to conduct the trials, and most of those expenses are recovered from government and non-government sponsors. More than 200 clinical trials are under way at ECU in many areas, including diabetes, cancer, heart disease, obesity and hypertension.
While clinical trials are an essential and irreplaceable last step in establishing new treatment approaches for any disease, they would not be possible without the willingness of patients to participate. They help physicians learn which treatments work better, cause fewer side effects, cost less or have other benefits.
"There's not a lot of robust data to say which is better," said Dr. Prashanti Atluri, a clinical assistant professor of oncology at ECU who sees Jones.
"So this is trying to answer the age-old question (of) are two drugs better than one, are chemo and radiation better or is just chemo better."
She said the incentive for patients to participate in clinical trials such as this one is altruistic: helping those who have the disease in the future.
Jones agreed. "If they learn something from me that can help someone else, I'm glad I've done it," she said. "I feel very, very blessed."
Pancreatic cancer is the fourth most common cause of cancer-related deaths in the United States, according to the Centers for Disease Control and Prevention. Patients have a poor prognosis; for all stages, the combined, the one- and five-year relative survival rates are 25 percent and 6 percent, respectively.
More information about cancer clinical trials at ECU is available at http://www.ecu.edu/cs-dhs/ecuphysicians/cancer/ClinicalTrials.cfm.