HEALTH MATTERS: AdventHealth, Moffitt Cancer Center partner for clinical trial

The two organizations are furthering cancer research and bringing hope to Central Florida patients through their first collaborative clinical trial.

By Danielle Hendrix
| 12:17 p.m. December 11, 2020

Health

With the launch of their collaborative clinical trial in Central Florida, AdventHealth and Moffitt Cancer Center are bringing a double-dose of expertise and research abilities to local patients.

In early September, the two organizations announced their Phase I trial testing the efficacy of a new combination therapy for lung cancer — one that could mean a world of difference for patients with non-small cell lung cancer, in particular. The trial is accruing patients at AdventHealth Celebration, where the Moffitt — AdventHealth clinical research unit is underway.

“The opening of this trial is the first visible benefit for patients to come out of our relationship with Moffitt Cancer Center,” said Dr. Steven R. Smith, associate center director of the AdventHealth — Moffitt Cancer Center partnership and chief scientific officer of the AdventHealth Research Institute Orlando. “This initiative is just the beginning of what we’ll accomplish together in advancing cancer care and research here in Central Florida.”

BLOSSOMING PARTNERSHIP

Before the collaboration on the clinical trial began, AdventHealth and Moffitt’s partnership had been a topic of discussion since 2016. It was finalized and formally announced in September 2019.

With the two joining forces, they are able to provide world-class cancer treatment as well as better access to cancer prevention, education, screenings and early-phase clinical trials. The announcement also launched the establishment of a clinical research facility and chemotherapy/immunotherapy infusion program at AdventHealth Celebration.

Meet The Organizations

AdventHealth

AdventHealth’s Central Florida Division comprises 23 hospitals and emergency rooms in the seven counties in and surrounding metro Orlando. Collectively, they provide care for more than 2,000,000 patient visits per year. The Central Florida Division’s care network also includes more than 30 CentraCare urgent-care centers; dozens of sports-rehab and imaging centers; and hundreds of physicians, ranging from primary care to a full spectrum of specialties. The system provides a wide range of health services such as cardiology, cancer, women’s medicine, neuroscience, diabetes, orthopedics, pediatrics, transplant and advanced surgical programs.

Moffitt Cancer Center

Based in Tampa, Moffitt is dedicated to specifically to contributing to the prevention and cure of cancer. It is one of only 51 National Cancer Institute-designated comprehensive cancer centers. Moffitt’s accomplishments are merited by its history of scientific excellence, multidisciplinary research, and robust training and education. It is the No. 11 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999.

The Clinical Combination

In AdventHealth and Moffitt Cancer Center’s collaborative clinical-research trial, researchers are overseeing the combination of two drugs — ceritinib (Zykadia) and docetaxel (Taxotere) — to gauge the efficacy of treatment when administered simultaneously.

Ceritinib — Known by brand name Zykadia, ceritinib is a prescription-only drug used for the treatment of non-small cell lung cancer. It was developed by Novartis and received FDA approval for use in April 2014. Ceritinib is a pill that patients take orally on a daily basis. It is primarily used to treat breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer, and metastatic prostate cancer.
Docetaxel — Known by brand name Taxotere, docetaxel is a form of chemotherapy that works by destroying quickly dividing cells, such as cancer cells. It is given intravenously through a drip in the arm or a central line. Each treatment takes up to an hour and is administered once every three weeks.

Not only did the partnership bring a clinical research facility and access to vital cancer care to Central Florida, it also brought new hope to local cancer patients.

“AdventHealth and Moffitt created our special partnership with the unified goal of improving access to leading-edge clinical trials to the residents of Central Florida at the Moffitt — AdventHealth Clinical Research Unit at AdventHealth Celebration,” said Dr. Louis Harrison, Moffitt vice president and chief partnership officer. “Bringing Moffitt’s clinical research expertise to the existing strengths of the Advent Health team creates a world-class opportunity to bring novel therapies to this community.”

Dr. Nikhil Khushalani — assistant center director of clinical research review and partnerships, and senior member of the Department of Cutaneous Oncology at Moffitt — said the partnership with AdventHealth is a natural fit.

“AdventHealth has really taken the lead there in ensuring those resources get put into the Celebration unit so we have an absolutely top-notch infusion facility where patients can come and get their treatment closer to home but with equal input from the Moffitt team, as well,” Khushalani said. “It was quite natural that this is a study that could be easily done within the AdventHealth campus. You want to choose studies initially that don’t have too many quirks in the conduct of the study … things that are pretty straightforward so that you make sure that it’s easy to do at a site that’s outside ‘the mothership.’ This was the perfect fit.”

COLLABORATION IN ACTION

Bringing an innovative, early-stage investigational therapy from Tampa to Central Florida is considered a major milestone for both organizations.

In AdventHealth and Moffitt’s collaborative trial, researchers are focused on discovering the effects of the drug ceritinib (Zykadia) used in combination with docetaxel (Taxotere) on participants with a specific type of non-small cell lung cancer. Both drugs are FDA-approved cancer treatments but had not previously been given simultaneously.

What Is Non-Small Cell Lung Cancer?

One of two main types of lung cancer, non-small cell lung cancer is the most common. According to the American Cancer Society, about 80% to 85% of lung cancers are NSCLC. The main subtypes are adenocarcinoma, squamous call carcinoma and large-cell carcinoma.

Adenocarcinoma: Occurs mainly in current and former smokers but is also the most common type of lung cancer seen in non-smokers. It is more common in women than men and is more likely to occur in younger people. Adenocarcinoma is usually found in the outer parts of the lung.
Large-cell carcinoma: This can appear in any part of the lung and tends to both grow and spread quickly, which can make it tougher to treat.
Squamous cell carcinoma: This starts in squamous cells, or flat cells that line the inside of the airways in the lungs. They often are linked to a history of smoking and tend to be found in the central part of the lungs, near a main airway.

Source: American Cancer Society

Dr. Andreas Saltos, principal investigator for the lung cancer trial, said the idea stemmed from Moffitt scientists, specifically Dr. Uwe Rix. A researcher with a background in chemistry and engineering, Rix has been conducting experimental screenings that consist of repurposing existing FDA-approved drugs for treatment of lung cancer.

“This combination was elected specifically because there was promise that these drugs worked in synergy with each other in preclinical research,” Saltos said. “The primary goal of the study is to find out if this combination of two drugs … is safe, tolerable and feasible to give … together. The secondary goal is to find out if this combination is more effective than just giving the docetaxel chemotherapy, which is the standard approach.”

Docetaxel is the “cornerstone drug” for patients with non-small cell lung cancer but is not always very effective, said Dr. George Simon, executive director of the Moffitt — AdventHealth Clinical Research Unit at AdventHealth Celebration.

“There is some benefit, but it doesn’t have a huge benefit,” Simon said. “So what we’ve been trying to do is augment the benefit of docetaxel. … What Andreas and his group did was say, ‘Let’s try to take a drug that is already available, FDA approved and used for another indication … and why don’t we see whether we can repurpose an existing drug and see whether we can augment the efficacy of docetaxel?”

There are a number of qualifications needed to participate in the trial. Saltos and his team specifically look for patients who have Stage 4 lung cancer that either has progressed or stopped responding to initial treatment.

Patients who are deemed potential candidates consult with their doctor and the team at AdventHealth and Moffitt to further determine their eligibility. Once approved for participation, they receive the medications either at Moffitt or at the AdventHealth Celebration research site.

“AdventHealth has really taken the lead there in ensuring those resources get put into the Celebration unit so we have an absolutely top-notch infusion facility where patients can come and get their treatment closer to home but with equal input from the Moffitt team, as well.” — Dr. Nikhil Khushalani

Ceritinib is an oral pill that patients take daily at home, while docetaxel is a form of intravenous chemotherapy that patients receive every three weeks. Participants also receive a safety assessment every three weeks, and an assessment of their cancer via scans every six weeks to see if the treatment is effective.

“Because this is the first time these drugs are given in combination, we actually started out by giving a lower dose of the drugs to the first participants,” Saltos said. “Once it was demonstrated that there were no safety concerns, we are able to escalate the dose sequentially. … The doses have been escalated a couple of times to where we are currently.

“The goal of this is to determine what the best recommended dose is for the combination of drugs, and thus far, we haven’t yet finally determined what that best combination dosage is,” Saltos said. “But there hasn’t been any indication that we’ve reached a dose that is intolerable at this point.”

The trial remains underway and is open for eligible participants. For both entities, the goal is to further cancer research and invest in the future of treatment options.

“One of our aims is the prevention and cure of cancer — that’s essentially our mission,” Khushalani said. “So it’s not only seeing patients and treating them with current standards of care, but in fact defining what the future standards of care could be and trying to … carve that path out for the future.”