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