Clinical trials at CarolinaEast offer cancer patients best care close to home

From New Bern Sun Journal
Posted Sep 2, 2020

Margaret Pardini of Havelock had lung cancer surgery Oct. 30 at the SECU Comprehensive Cancer Center at CarolinaEast Medical Center.

As with most cancer patients preparing to undergo chemotherapy, Pardini was concerned about its common side effects – nausea and vomiting. A widow, Pardini also was concerned about the financial burden she might face from taking an expensive drug routinely given to combat those side effects.

“Granted, I do have insurance, but I don’t know how far the insurance would have paid and how I would have survived having to pay for an expensive drug,” she said.

Because CarolinaEast is part of the Southeast Clinical Research Consortium, supported by the National Cancer Institute, Pardini was able to enroll in a clinical trial at the hospital before starting chemo in January.

The trial tests the effectiveness of Olanzapine, an FDA-approved anti-psychotic drug, with or without the more expensive standard-of-care drug fosaprepitant in preventing nausea and vomiting in patients receiving chemotherapy, said Lynn Harrison, clinical research nurse at the cancer center.

“One of the major fears of patients when they are about to get chemotherapy is that they’re going to have nausea and vomiting,” Harrison said. “It is considered by patients to be a severe side effect.”

The study is gathering further evidence that Olanzapine should be recommended for use to help with chemotherapy-induced nausea and vomiting, she said.

Study participants are divided into two groups. One group receives Olanzapine and three other drugs, including fosaprepitant. The second group receives the same drugs except for the fosaprepitant, which is replaced with a placebo, a substance with no effects.

Pardini later found out she was in the group that received Olanzapine and the other drugs, but a placebo instead of fosaprepitant.

She said she was a little afraid of receiving chemo because everybody told her she would get sick.

“I never got sick, which was great on my part,” Pardini said. “I had no ill effects from being in this study at all.”

Harrison said just because Pardini’s experience during chemotherapy was side-effect free, researchers can’t generalize that’s going to be the result of the study overall.

“That’s just this patient’s experience,” she said.

Harrison said Pardini’s participation in the trial was double-blind during the first cycle of chemotherapy.

“I don’t know what she’s getting, the doctor doesn’t know what she’s getting, and the patient doesn’t know what she’s getting,” Harrison said, referring to the anti-nausea drugs. “In her case, she got placebo.”

If the patients have no nausea and vomiting, and they want to continue with the study for the remainder of their chemotherapy, they let the research staff know, she said.

“We unblind everyone so that we know what the patient got and then we continue to let them receive exactly what they got in the first cycle,” Harrison said. “Then we continue to collect data about their side effects, nausea and vomiting, and whether they had to take any relief medication for breaks from nausea.”

Pardini said she had a great experience at the cancer center and in the trial.

“I couldn’t ask for better care than what I got,” she said. “They kept me informed. They were always there for me.”

Her fourth and final cycle of chemo was March 10, but Pardini’s participation in the trial continued for a month afterward so she could be monitored for side effects and adverse events, Harrison said. Pardini completed the study April 10.

So far, the hospital has had five patients complete the phase III randomized, double-blind, placebo-controlled trial that was opened in 2018, Harrison said.

“In the cancer center we have about 10 interventional trials – sometimes called treatment trials – open,” she said.

Including other trials, such as those that look at the way the center delivers cancer care, the hospital has a total of about 13 studies currently open.

Harrison said she joined CarolinaEast in 2016 because the cancer center needed a research program at the community level to offer its patients opportunities to participate in clinical trials.

Clinical trials are now considered the best care of a patient who has cancer, Harrison said.

“There’s a misconception that trials are only to be offered to patients who don’t have any other alternatives, or they’ve exhausted all other therapies,” she said. “But that’s not the case anymore. Trials should be looked at as treatment options. We have so many different types of trials that they can sometimes be used from the point of diagnosis.”

Trials are generally covered by health insurances and Medicare, Harrison said. Patients still should get prior authorization before participating, she said.

Because CarolinaEast is a member of the Southeast Clinical Research Consortium, funded by the National Cancer Institute, the hospital has access to multiple research organizations that write research protocols and offer those at the community level, Harrison said.

The trial Pardini participated in is a National Cancer Institute-supported trial and the research base for the trial is the Alliance for Clinical Trials in Oncology, Harrison said.

“What we’re doing here is participating in practice-changing research,” she said. “It’s really exciting for us to be able to offer this to our patients locally at home instead of them having to travel to UNC or Duke to get a therapy that’s cutting edge.”

CarolinaEast opens doors on new SECU Comprehensive Cancer Center

From New Bern Sun Journal
By Todd Wetherington, Jan 17, 2020

SECU Cancer Center opens at CarolinaEast Medical Center in New Bern, NCCity officials, donors and members of the media got a first hand look at the new SECU Comprehensive Cancer Center at CarolinaEast Medical Center Thursday.

Located on the west side of the Medical Center’s main campus in New Bern, the three-story Cancer Center will offer radiation oncology, medical oncology, nutrition services, social worker and psychological support services, and a palliative care and survivorship program, among other services.

In November 2014, CarolinaEast Medical Center and UNC Cancer Care announced a collaboration to bring comprehensive cancer services previously available only in the Raleigh/Durham Triangle region to the eastern part of the state. Ground was broken on the 80,000 square feet, $37 million Cancer Center in January 2017. The first floor features a radiation oncology clinic and treatment areas, an infusion suite with six semi-private infusion bays and two private rooms, a specialty pharmacy, a cafe, a boutique with oncology-related supplies, group support session rooms, and palliative care. The Cancer Center’s second floor includes a medical oncology clinic with 12 exam rooms and six patient assessment bays, an infusion suite with both semi-private and private rooms, and a chemotherapy mixing pharmacy. The third floor is devoted to administration offices and an education department with classrooms and computer labs.

According to Brandy Popp, CarolinaEast Health System public relations and outreach manager, the Cancer Center will begin receiving patients on Monday, Jan. 20. Popp said an open house, ribbon cutting ceremony for the public is planned for Saturday, Jan. 25.

A new $13 million diagnostic center is also nearing completion adjacent to the Cancer Center to facilitate efficient imaging services related to cancer prevention, treatment and diagnosis. UNC Health System will collaborate to provide access to clinical trials, outreach, and telehealth.

2019 Colors for Cancer to benefit Journey of Hope

A 10K/5K/1 Mile powdered COLOR run to benefit the Journey of Hope Cancer Support Center.

2019 Craig Brake Memorial Colors 4 Cancer 10k, 5k and 1 mile run/walk is a color run which benefits the Journey of Hope Cancer Support Center in New Bern, NC. Journey of Hope helps patients and families cope with the emotional, physical, and psychological effects of cancer by offering programs such as peer support groups, survivorship program, art therapy, yoga/exercise, and other various programs. We are a comprehensive cancer resource center in Eastern North Carolina for people with cancer and their caregivers, to let them know they are not alone and we are here to support them in all aspects of this journey. We are a non for profit organization that supports 100% LOCAL people/families. >>READ MORE

Cancer Center at CarolinaEast Medical Center

Posted Jun 26, 2019

SECU Comprehensive Cancer in New Bern NC is a SCOR member site NCORPWhile UNC and Duke are frequently in the news for medical research, cancer patients at CarolinaEast Medical Center can participate in national clinical trials without leaving New Bern.

One of those trials looks at treatment options for a precursor to breast cancer. The trial is named COMET, which stands for comparison of operative to monitoring and endocrine therapy for low-risk ductal carcinoma in situ (DCIS). The study enrolled 1,200 women at cancer centers across the United States, including at CarolinaEast.

Among other clinical trials underway at CarolinaEast are studies that involve lung cancer, colorectal cancer and prostate cancer, said Dr. Seth Miller, radiation oncologist and director of clinical trials.

“The goal is to open studies that are likely to be high-yield, high-accruing trials for patients in the disease types that are most representative,” Miller said. “We won’t necessarily open things that are more orphan-like. That’s probably going to remain at the university level. But big disease sites, opportunities where we can enroll a number of patients, are really what we’re focusing our initial efforts on.”

He said none of these studies are investigator-initiated trials at CarolinaEast’s level.

“We have the ability to open trials of that nature, for example if UNC or Duke had something really innovative that one of their investigators had initiated, but we focused on national, multi-institutional, largely randomized studies,” Miller said.

Patients participating in clinical trials receive at minimum of the standard care for their illness, he said.

“The investigative arm is looking at how to build upon the standard of care or the gold standard,” Miller said. “So, every patient in a trial is getting at the very least the gold standard and they’re potentially adding additional therapy that may even further improve outcomes or opportunities.”

Trials questions sometimes don’t show a benefit or, in retrospect, were more harmful than helpful to patients, he said.

Nearly all the physicians in the CarolinaEast cancer center are leading or co-principal investigators on a trial, Miller said. All investigators must meet regulatory and training guidelines.

“Lynn Harrison, our research coordinator, has been diligent on keeping us all in check, making sure we are both up to date on our training and renewed annually, so this is a huge effort on her part,” he said.

Physicians found the added paperwork valuable because it allows them to offer state-of-the-art care beyond the current standard because of clinical trial opportunities, Miller said.

“For each of the individual physicians, we’ve all had to personally say, ‘This is a really important part of how we take care of cancer patients in New Bern and the surrounding community,’” he said.

“The only way that we’re going to increase rates of cure, reduce toxicity and provide new treatment options for patients is through well-structured clinical research,” Miller said. “Being able to offer those trials at the local level provides not only additional opportunities close to home for patients, but it also sharpens the physicians.”

Miller is the principal investigator on three studies that are part of the CarolinaEast clinical trials portfolio as well as on a legacy trial for a former study opened at the hospital.

“Being a principal investigator at the community setting, or the co-PI, requires us to know the details of those studies and it creates constant dialog about potential new studies and findings that come from previously completed studies,” he said. “It sort of advances our knowledge in an ongoing and continuous way while affording patients additional close-to-home treatment options.”

As director of clinical trials, Miller works closely with Harrison to look at future trial opportunities and assess the CarolinaEast trials portfolio and enrollment goals.

He also participates in monthly phone calls with the Southern Consortium of Oncology Research, a group based out of Winston-Salem that has funding from the National Cancer Institute to further structure clinical trials enrollment in the community.

Miller said doctors involved in clinical research do so on top of their expected full-time clinical obligations.

“I think that speaks to all of our commitments to adding a research component to what we can offer here locally because it’s not something that’s carved out of our schedules per se, but rather something we’re doing in addition to our commitment to taking good clinical care of the patients in the first place,” he said.

CarolinaEast’s commitment to build a comprehensive cancer center preceded Miller’s arrival in August 2015.

“The things that go into that require some robust commitments financially from the time and staffing standpoint that don’t necessarily return revenue dollars, if you will.,” he said.

“I think clinical trials is one component that the health system has said, ‘If we’re going to make this robust comprehensive cancer center a reality, we’re going to have to support that in time, effort and financially.’ And they’ve done that to the fullest that I think should so far to date.”