The first clinical trial to compare standard of care chemotherapy with molecularly tailored therapy (also known as precision medicine) for metastatic pancreatic cancer began enrolling patients at Georgetown Lombardi Comprehensive Cancer Center this summer.
The phase II study, which involves four other cancer centers around the country, will enroll about 60 patients. Patients who have been treated with one round of chemotherapy for metastatic pancreatic cancer and have stable disease as determined by screening may be eligible. Half will be randomly assigned to receive standard of care chemotherapy regimens—two are in use today—and the other half will have their tumors analyzed using state-of-theart laboratory tests designed to match treatment to the genes and proteins making their cancers grow and spread.
“In the molecularly tailored group, we will be harnessing any and all available resources to provide patients with the right drugs to treat their tumors,” says Georgetown Lombardi oncologist Michael J. Pishvaian, MD, PhD, principal investigator of the clinical trial who sees patients at MedStar Georgetown University Hospital.
For example, if a patient’s tumor reveals molecular pathways found in breast or ovarian cancer, drugs for those tumor subtypes will be used.
“We may find that some patients do better with standard of care therapy because their tumors use pathways for which we do not have a targeted therapy, and that other patients respond well to targeted treatments for which we have an agent,” Pishvaian says. “I am certain we will learn a lot about what drives pancreatic cancer, what we can use in our medical toolkit, and what we need to develop as novel treatments.”
The $1 million study is being funded by the American Association for Cancer Research (AACR) and the Pancreatic Cancer Action Network (PanCAN). The other co-leading institution is Thomas Jefferson University in Philadelphia, which will molecularly model individual tumors. The study is also being funded or supported in part by Caris Life Sciences, Inc.; Guardant Health, Inc.; and Theranostics Health, Inc. Pishvaian has been a paid scientific consultant for Caris Life Sciences.
Margaret Foti, PhD, AACR chief executive officer, underscores the urgent need for research into the deadly disease.
“Pancreatic cancer is one of the few cancer types for which death rates are steadily increasing,” says Foti. “It is projected to become the second leading cause of cancer-related death in the United States by 2030.”