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Clinical Trials Key to Survival for Pancreatic Cancer Patients

David Bajor, MD and George Miller

George Miller first suspected he had the flu when a severely upset stomach, vomiting and a persistent, painful case of the hiccups landed him in the ER at University Hospitals Samaritan Medical Center.

The 63-year-old man was devoid of energy and had lost 30 pounds in a few weeks. The vague symptoms are a hallmark of pancreatic cancer, which according to an oft-cited research study, will be the second-leading cause of cancer deaths by 2020. No diagnostic tools exist to catch this cancer in its early stages. But early medical attention can lead patients to treatment.

Fortunately for George, the ER closest to his rural Ashland County home is affiliated with University Hospitals, where patients are being enrolled in promising clinical trials to combat this insidious disease. Every treatment available today was established through a clinical trial, according to the Pancreatic Cancer Action Network.

Recognizing the signs

Pancreatic cancer spreads early in the course of disease, when the tumor is still the size of a golf ball or smaller,” says Jordan Winter, MD, UH’s Chief of Surgical Oncology and a nationally recognized expert on pancreatic cancer. “This is not true for so many other common cancers, and we have not figured out why pancreatic cancer is so aggressive. The cancer often presents with very vague and non-specific symptoms, which further delays diagnosis.

Symptoms of pancreatic cancer can be very nonspecific. They include:

  • Lower back or abdominal pain
  • Unexplained weight loss and/or loss of appetite
  • Jaundice, a yellowing of the skin and/or eyes
  • Changes in stool
  • Pancreatitis or inflammation of the pancreas
  • Recent-onset diabetes

Nearly half of patients with early pancreatic cancer present with recent-onset diabetes, depression, and unintentional weight loss, Dr. Winter says. Jaundice is common when the bile duct that runs through the head of the pancreas becomes blocked. Greasy diarrhea may result from a tumor blocking the patient’s pancreatic duct, inhibiting the digestion of fats.

“We believe very strongly that early referral to a surgeon is critical, especially for patients with localized disease,” Dr. Winter says. “We want to meet the patient in person or by phone the day they are discovered to have a pancreatic mass. It is problematic when patients circle through the health system before they meet a pancreatic surgeon. We can be the quarterback or navigator, even if they do not need surgery right away.”

Connections to care

George’s pancreatic mass was discovered by Dale Thomae, MD, a gastroenterologist at UH Samaritan, who quickly referred him to specialists at UH Cleveland Medical Center. Jeffrey Hardacre, MD, a surgeon specializing in and who leads research in pancreatic cancer at UH Seidman Cancer Center, facilitated George’s care at UH Cleveland Medical Center.  He referred George to interventional gastroenterologist Ashley Faulx, MD, who was able to clear a blockage in George’s duodenum by inserting a stent, which allowed him to eat.

Dr. Hardacre and medical oncologist David Bajor, MD, then enrolled George in a clinical trial of an investigational immunotherapy agent given in the preoperative setting. Immunotherapy primes the immune system against the tumor and, when used in conjunction with chemotherapy, kills the tumor cells.

“The immunotherapy also activates the immune system to ‘pay attention’ to the dying cancer cells,” Dr. Bajor says. “The resulting immunological memory could, in theory, protect the body against cancer recurrence.” 

After the preoperative therapy, Dr. Hardacre performed a Whipple procedure – a complex procedure that involves removing part of the pancreas, duodenum, bile duct, and gallbladder. In addition to the Whipple, a hemicolectomy – a procedure that removes part of the colon – was also needed to remove George’s cancer.

George spent 20 days in the hospital after the operation, but recovered well and continues to receive postoperative immunotherapy and chemotherapy. His scans now show no evidence of tumor.

“Clinical trials are critical to improving patient outcomes, particularly for diseases like pancreatic cancer where our standard treatments fall far short of what we like to be able to do for our patients,” Dr. Hardacre says.

Promise for the future

Clinical trials are also vital for patient survivability and progress in treating this difficult disease. Only 5 percent of pancreatic cancer patients participate in clinical trials, but Dr. Winter is pushing to make it closer to 80 percent.

“We just can’t make progress unless we enroll patients, and if we do a better job of this, progress will come much faster,” Dr. Winter says. “At UH Seidman Cancer Center, we are populating our clinical trial map with extreme urgency.”

Dr. Hardacre is the principal investigator of a clinical trial for patients with locally advanced pancreatic cancer that has not metastasized. His trial adds a new drug, CPI-613, to target the mitochondria or energy-producing center of cancer cells, in conjunction with the best available regimen, which is a combination of three drugs.

“This is an extremely promising trial,” Dr. Winter says. “In the early trial testing of this drug, the complete response rate was 40 times higher than historical experience. We hope this signal persists. We are the only center to offer this trial.”

UH also is extending hope to patients with metastatic pancreatic cancer who have not had first-line chemotherapy. Another clinical trial is working to mobilize the patient’s own immune system to fight advanced pancreatic cancer.

"Knowing they have chosen a hospital with promising options for treatment makes the 100-mile drive from home worthwhile," says George’s wife, Maryann. “Our doctors have been fantastic, answering questions in terms we could understand and very personable,” she adds. “I knew pancreatic cancer was very serious, and we had to hit it hard.”

Every week, George feels a little bit stronger. He’s happy to be finished with chemotherapy and now only needs periodic visits to UH Seidman Cancer Center on main campus. He is in no pain and said he feels just as he did before the unexpected symptoms that landed him in the ER last February.

Dr. Bajor remains “cautiously optimistic.”

“This disease makes you a humble doctor,” Dr. Bajor told George during a recent office visit. “Without the clinical trial the odds are stacked against us. Hopefully what we are able to do gives you a fighting chance.”