Clinical Trial Examines Coupling Chemotherapy, Radiation for Locally Advanced Pancreatic Cancer

CINCINNATI—Researchers at the UC Cancer Institute are conducting a clinical trial to see if using combined chemotherapy medications along with chemoradiation could improve outcomes for patients with locally advanced pancreatic cancer.

Locally advanced pancreatic cancer is a tumor that has involved the major blood vessels around the pancreas.

This study will build on existing findings from the UC pancreatic cancer research team to determine if the combination is beneficial or proves to be a better treatment for patients.

UC Cancer Institute researchers Olugbenga Olowokure, MD, assistant professor in the division of hematology oncology, and Michelle Mierzwa, MD, assistant professor in the department of radiation oncology, at the UC College of Medicine, are the co-principal investigators on the study.

"Pancreatic cancer is the fourth-most common cause of cancer-related death in men and women in the United States,” says Olowokure. "The five-year survival rate is around 6 percent. Approximately 30 percent of patients are diagnosed with locally advanced disease when the cancer is found. Locally advanced pancreatic cancer is non-metastatic (hasn’t spread to other organs) but cannot be completely surgically removed.

"A series of trials conducted over the past two decades have shown that chemoradiation therapy is beneficial for these localized tumors, and more recent studies have suggested that chemotherapy might be the critical component in the treatment approach and that combined treatment with chemotherapy and chemoradiation therapy may be a more effective, though more toxic, approach.

"In this study, which was developed based on our pancreatic cancer team’s local treatment experience and reported at the national American Society of Clinical Oncology meeting in 2012, we want to see if the combination of two FDA-approved pancreatic cancer chemotherapy treatments—Gemcitabine and Abraxane —along with escalated doses of radiotherapy is beneficial for these patients.”

In the trial, patients will receive two 28-day cycles of the chemotherapy combination with Abraxane at 100 mg/m2 and Gemcitabine at 1,000 mg/m2 on days 1, 8 and 15 prior to the start of Gemcitabine-based radiation. This would begin two weeks after the completion of the second cycle of the combination.

"Patients will receive an additional two cycles of the combination to start about two to four weeks after the completion of the Gemcitabine-based chemoradiation,” says Olowokure. "After the last two cycles of chemotherapy, if well tolerated with continued tumor shrinkage or stable disease, additional cycles of chemotherapy may be given. If at any point a patient’s tumor is deemed removable, the patient will have their pancreatic tumor surgically removed.”

The clinical trial is projected to take place for about six years in which time patients will continue treatment and their outcomes and side effects will be recorded.

"We hope to determine whether or not this combination of treatments is beneficial and improves survival of patients with this type of pancreatic cancer, potentially adding another successful treatment for this type of cancer which has few,” he continues.

This clinical trial is investigator-initiated and is supported by UC’s division of hematology oncology and the department of radiation oncology.