Inside a Clinical Trial: Patient Profile of Demetrios

After experiencing an unexplained abdominal pain, Demetrios went to the ER and had CT and MRI scans that detected an abnormality. Pancreatic cancer was diagnosed after an endoscopy and biopsy. Demetrios had surgery on his pancreas to treat the cancer, but a few months after the surgery he felt a different kind of pain in his abdomen so went back to the ER. That hospital visit revealed that the original pancreatic cancer had metastasized to his liver.

Stage IV of any cancer is a challenging diagnosis, but stage IV cancer that has spread to the liver carries a devastating prognosis.

It was during that second ER visit that Demetrios met Dr. Srilata Gundala, founder of Hope & Healing Cancer Services in Hinsdale, Illinois. He opted to shift his treatment to her clinic given the new metastasis in his liver. The clinic was close to his home and Demetrios appreciated Dr. Gundala’s bedside manner. “It’s a nice experience at Hope & Healing,” says Demetrios, “easy for me to get to and comfortable.”

A standard protocol of chemotherapy was started, but that treatment resulted in spiking blood sugar levels for Demetrios that were unsustainable. Dr. Gundala approached Demetrios about enrolling in a clinical trial for a new chemo protocol tailored to his needs. Demetrios was on board, “It feels okay. I don’t have too many fears. The treatment is free, and that makes a difference for me.”

Collaborating with Ava Baftirovska, Research Manager at Hope & Healing, Dr. Gundala was able to find a clinical trial that looked promising for Demetrios. In general terms, clinical trials are broken down into three separate phases. After phase III of a clinical trial, researchers can apply to the Food & Drug Administration (FDA) for approval.

·      Phase I – Works to establish parameters for safety and dosage levels in human subjects; usually involves 20-100 volunteers.

·      Phase II – Works to determine the effectiveness of an experimental drug on a particular disease; usually involves 100-300 volunteers.

·      Phase III – Testing of the experimental drug is scaled up to involve several hundred to several thousand volunteer patients in many different settings.

With clinical trials being the foundational building blocks of future cancer treatments, they involve additional layers of scrutiny and support. How does this impact patients like Demetrios? Ms. Baftirovska explains, “Patients benefit from closer monitoring and an intensive level of medical care and oversight. Not only is there the possibility of individual health improvement, but patient volunteers help future generations with their outcomes, too.”

Demetrios, then, is one of 100 - 300 volunteers enrolled in a phase II clinical trial to assess the effectiveness of an experimental drug impacting patients with cancer metastasized to their livers. When asked about what it is like to contribute to advancements in cancer treatment, Demetrios is caught off guard, “I didn’t think about how I am helping others until asked that question,” he says, “I like that. I hope it will cure me and help other people.”

So, is the clinical trial helping? Yes, resoundingly so.

Demetrios’ phase II clinical trial requires CT scans to be completed every six weeks. “His scans are showing rapid improvement. The third set of scans was just done,” says Ms. Baftirovska, “and all of us are so pleased for him.” Demetrios adds, “I was happy, and they were happy.”

For Dr. Gundala, ‘happy’ is an understatement, “This is almost unheard-of progress. The scans from December until now show great strides and immense progress. Our research team goes above and beyond to connect patients with the best trials that offer the most promise for them. The response that Demetrios is showing is more than we could have hoped for, but what we wish for all our patients who opt in to a clinical trial matched to their unique needs.”

Patients who qualify for clinical trials are those patients, for whatever reason, who have not responded to more standard protocols. “Clinical trials provide options when there are none,” says Dr. Gundala. That is why it became so important to her to offer clinical trials as a path forward for patients that did not respond to other treatments. “You don’t need to choose a university setting or large hospital system for the best advancements in cancer treatments. My patients can stay close to home and be assured they have access to the best care for them, whatever that may be.”

When standard treatments do not address a challenging situation like stage IV metastatic cancer, it is common for patients in Demetrios’ shoes to feel hopeless and give up. Clinical trials provide an additional tool for Dr. Gundala and her patients.

“It was my dream to be able to provide this, and now it is reality for my patients,” says Dr. Gundala, “Clinical trials provide that hope that my most vulnerable patients need. Those positive results that Demetrios is seeing, when they did not seem possible even a few months ago, are tangible proof of the value of clinical trials.”

Written By: Sheila Quirke, MSW

Reviewed By: Srilata Gundala, MD