Clinical trials program offers FirstHealth patients treatment options

Charles Kuzma, M.D.

John Byron, M.D.

PINEHURST – Carolyn Ali is glad that she took part in a clinical trial at FirstHealth Moore Regional Hospital.

Although her study found no discernable difference in the results of the two breast cancer drugs that it compared, Ali says she had excellent care during her time of participation and got all of the study medication she needed – in an accepted program of treatment for her diagnosis – at no cost.

“I’d encourage others to do it,” she says.

Clinical trials are tightly controlled tests that evaluate the effectiveness and safety of new drugs or medical devices before they are made available for general clinical use. Moore Regional Hospital has had a program since 1995.

Some trials, including the one in which Carolyn Ali took part, are international in nature and involve hospitals, patients and physicians from several countries throughout the world. Any trial that is offered in the United States is conducted under the direction of the federal Food and Drug Administration.

Patients in community hospitals like Moore Regional usually don’t have the opportunity to participate in the cutting-edge treatment of clinical trials. The programs are more likely to be associated with much larger facilities – often with academic institutions.

“Most residents of rural areas don’t have access to these opportunities without traveling great distances,” says Chris Miller, interim director of FirstHealth Community Health Services.

Charles Kuzma, M.D., the principal medical oncology investigator for Moore Regional’s Community Clinical Oncology Program (CCOP), agrees. “The access to trials in this community is something that most people in rural areas do not have,” he says.

Moore Regional’s CCOP is part of the Winston-Salem-headquartered Southeast Cancer Control Consortium (SCCC), which is affiliated with the National Cancer Institute. More than 100 medical oncologists, radiation oncologists, surgeons and urologists in 21 institutions/hospitals in five states participate in SCCC cancer research.

Other SCCC programs are located in the North Carolina cities of Asheville, Cary, Charlotte (at both Carolinas Medical Center and Presbyterian Hospital), Gastonia, Goldsboro, Greensboro, Hendersonville, High Point, Raleigh (at the Cancer Centers of NC), Statesville and Winston-Salem. There are also programs in Virginia, Tennessee, South Carolina and Georgia.

With 29 cancer trials currently being offered, Moore Regional is a major SCCC participant and was one of its largest enrollers in 2010. The goal, according to Dr. Kuzma, is to open one or two new trials every month.

“It’s something to be proud of,” he says. “We can offer certain treatments that other hospitals don’t offer.”

Moore Regional’s clinical trials target patient needs, Dr. Kuzma says, and focus on the types of cancer that are most often treated through the hospital’s Community Hospital Comprehensive Cancer Center program.

“We focus on breast, prostate, lung, colorectal, gynecologic, lymphomas, brain, and head and neck,” he says, “with breast, lung, colorectal and prostate making up about 70 percent.”

The goal is simple and straightforward: “To improve the treatment of cancers and to improve the quality of life of our patients,” Dr. Kuzma says. “It also allows future (treatment) decisions to be made on fact, not anecdote.”

According to John Byron, M.D., an OB/GYN specialist with Southern Pines Women’s Health Center, clinical trials give patients access to state-of-the-art care that they might not get otherwise.

Dr. Byron is the principal investigator for gynecologic oncology trials at Moore Regional, and his patients have participated in a number of studies.

“There are many medical conditions, whether they are life-threatening illnesses or chronic disease processes, for which there is no good therapy,” he says. “Before you can even have a clinical trial of a drug, a lot of research has already been done and it has shown some probable beneficial effect. So, if your patients can be in a trial of that drug, they might be years ahead of most other people with the same condition in actually getting the benefit of the drug.”

The study in which Carolyn Ali was enrolled compared two aromatase inhibitors (a class of drugs used in the treatment of breast cancer and ovarian cancer) in postmenopausal women with hormone-receptor-positive breast cancer. Although final results didn’t show a measurable difference in the ability of the two medications to reduce the risk for breast cancer recurrence or death, the study did highlight a noticeable difference in cost.

One of the drugs, anastrozole, is available generically for about $16 while the other, examestane, is not off patent and costs around $400. That’s an important consideration for a patient dealing with the significant expense of cancer treatment.

“The study showed equal support for each medication,” says Pat Young, a nurse in FirstHealth’s clinical trials program. “Now the cheaper one can be prescribed. It’s just as good a drug with a lesser cost.”

Despite their research-based nature, cancer clinical trials always provide patients with the current standard of care or with care that is enhanced by a new treatment that study sponsors believe is as good as or better than the standard of care. Most clinical studies randomize the patients to a specific treatment arm in a random manner, often by computer.

“Patients are followed closely,” says Young, “not only by clinical trials staff, but by their personal physician as well. That’s part of the study design.”

All patients enrolled in a particular trial receive the same treatment, Dr. Byron points out, whether they’re being treated at Moore Regional or at the Mayo Clinic. “All the smartest people looking at this particular cancer and the treatments have come up with what they think is the best way to treat it, and everybody has to follow the same recipe,” he says.

At Moore Regional, virtually every patient is considered to be a candidate for a study, but various factors eliminate most.

“We always try to consider a clinical trial for all patients,” says Dr. Kuzma, “but sometimes patients are uncomfortable about participating. Sometimes there are other health problems or logistics. And you don’t get to choose your treatment. Sometimes your doctor doesn’t get to choose.”

As a result, only 5 or 6 percent of Moore Regional’s cancer patients will actually participate in a clinical trial.

Although most of the clinical trials currently being conducted at Moore Regional involve cancer patients and cancer prevention, others focus on patients with heart or vascular disease. One current study compares methods of rehabilitation in people who are having trouble walking after a stroke.

In addition, Moore Regional is also one of only 15 sites nationwide participating in a new study on medications to treat premature labor.

Like all institutions that conduct medical research, Moore Regional operates its clinical trials program under the auspices of an Institutional Review Board (IRB). The local Sandhills Multi-Institutional IRB reviews all research that involves patients, and has one major responsibility: to assess the safety and ethical nature of the proposed research.

Since hospitals are not required to offer a clinical trials program, those that do are giving their patients a special opportunity for cutting-edge care.

“All of us do this for the love of oncology and the care of our patients,” Dr. Kuzma says. “It’s extra work, and it means more tests for patients. We do it, because it’s the right thing to do. It’s not always the easiest thing, but it's the right thing. It allows us to be on the vanguard of oncology breakthroughs.”

For more information on clinical trials and the clinical trials available at FirstHealth Moore Regional Hospital, call (910) 715-2200 or visit FirstHealth’s clinical trials website at www.firsthealth.org/clinicaltrials.