Atlantic Health System starts enrolling patients in four pancreatic cancer clinical trials

Atlantic Health System is now enrolling patients in four pancreatic cancer clinical trials. Angela Alistar, MD, a nationally known expert on pancreatic cancer, is serving as national Principal Investigator (PI) on the first trial and as local PI on three other trials. In addition, Dr. Alistar will serve as a national and local PI on three additional clinical studies open to enrollment later this year.

"We are fortunate to be able to offer these studies to people with this difficult-to-treat, aggressive cancer," said Dr. Alistar, who serves as director of GI medical oncology at the Carol G. Simon Cancer Center of Morristown Medical Center, Atlantic Health System. "Our pancreatic cancer program is unique, and our ability to provide access to these clinical trials is one important aspect of our uniqueness. New and more effective treatments are desperately needed."

Five-year survival rates for pancreatic cancer are low, even when caught early. In 2016, pancreatic cancer moved from the fourth leading cause of cancer-related deaths in the U.S. to the third, surpassing breast cancer.

"Dr. Alistar is a leading figure in GI cancer research and treatment, and she has significantly enhanced our ability to care for our patients," said Eric Whitman, MD, medical director, Atlantic Health System Cancer Care. "She has expanded Atlantic Health System's ability to offer participation in clinical trials for pancreatic cancer and other gastrointestinal malignancies, as well as the latest treatments, such as those that work with patients' immune systems to destroy cancer cells."

Pancreatic cancer studies that are currently enrolling patients include:

• Phase 1 Study of CPI-613 in Combination with Gemcitabine and Nab-Paclitaxel for Patients with Locally Advanced or Metastatic Pancreatic Cancer. This is a single arm, open-label study of CPI-613, a first-in-class drug with a unique mode of action, in combination with chemotherapeutic agents gemcitabine and nab-paclitaxel. The study, which is funded by Raphael Pharmaceuticals, Inc., is designed for patients with locally advanced or metastatic pancreatic cancer never treated with systemic chemotherapy. Atlantic Health System is the only program in the world to offer this promising study. Dr. Alistar led previous studies of this promising drug with pancreatic cancer activity, which have been presented at major international scientific meetings and published in The Lancet Oncology. NCT03435289
• Phase 2 Study of the Antioxidant BPM31510 (Ubidecarenone, or CoQ10) Nanosuspension Injection Administered Intravenously With or Without Gemcitabine as 2nd/3rd Line Therapy in Advanced Pancreatic Cancer Patients. This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and effectiveness of BPM31510 administered as a 144-hour continuous intravenous infusion by itself or in combination with gemcitabine in advanced pancreatic cancer patients as a 2nd / 3rd line therapy. The study is sponsored by Berg LLC and is open at seven total sites in the U.S. Atlantic Health System is the only study site in New Jersey and New York. NCT02650804
• An SU2C Catalyst® Randomized Phase II Trial of the PD1 Inhibitor Pembrolizumab With or Without Vitamin D Receptor Agonist Paricalcitol in Patients With Stage IV Pancreatic Cancer Who Have Been Placed in Best Possible Response. Chemotherapy regimens for pancreatic cancer can now stabilize a patient's cancer and/or place some patients in remission or partial remission. The challenge now is to find options for maintenance therapies that will improve survival and allow continued benefits with minimal toxicities and inconvenience to patients. This study will determine the effects of immunotherapy as one possible maintenance regimen. The study is being conducted to determine the effects that pembrolizumab with or without the addition of paricalcitol may have on pancreatic cancer. Half of the patients will be randomized to receive pembrolizumab (Keytruda?, a monoclonal antibody) plus paricalcitol (synthetic Vitamin D) and half to receive pembrolizumab plus placebo. This study is sponsored by The Translational Genomics Research Institute. Atlantic Health System's Morristown Medical Center is the only center on the East Coast that has this study open. NCT03331562
• Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas. The purpose of this study is to determine the best sequence of chemotherapy and chemoradiotherapy prior to surgery. This study is sponsored by Alliance and is open nationwide. NCT02839343 Each study has specific criteria for participation.