Atlantic Health System Cancer Care enrolling patients in five pancreatic cancer studies

November is National Pancreatic Cancer Awareness month. This year alone, more than 56,000 Americans will be diagnosed with pancreatic cancer. Pancreatic tumors are particularly aggressive and hard to treat "due to a mutational profile that makes it resistant to therapies that work better for other tumor types," explains Angela Alistar, MD, medical director of GI Oncology at Morristown Medical Center.

"We know that every patient has a different kind of pancreatic cancer, and therefore will have different outcomes, different tolerances to treatments and different responses to treatments," says Dr. Alistar.

Dr. Alistar, an internationally known expert on pancreatic cancer, is now enrolling patients in five clinical trials aimed at pancreatic cancer.

Pancreatic cancer is one of the deadliest cancers, but there are many different ways to try and change the fate of pancreatic cancer," adds Dr. Alistar, who is also medical director of the phase 1 Breakthrough Treatment Center at Morristown Medical Center. "What makes me optimistic about treating pancreatic cancer is clinical research, because I know that one day we will break through."

Angela Alistar, MD, medical director of GI Oncology at Morristown Medical Center

According to the American Cancer Society, 5-year survival rates for pancreatic cancer are low, even when caught early, before it spreads. In 2016, pancreatic cancer moved from the fourth leading cause of cancer-related deaths in the U.S. to the third, surpassing breast cancer.

"Exciting clinical trials are shining a light on our hope to defeat this illness in the near future," says Dr. Alistar.

Pancreatic cancer studies that are currently enrolling patients include:

• The TIGeR-PaC Study for Locally Advanced, Inoperable Pancreatic Cancer. In this unique Phase 3 study, participants will have chemotherapy delivered directly to their tumor via a catheter threaded through an artery (intra-arterial treatment). Patients will first receive intravenous chemotherapy drugs gemcitabine plus nab-paclitaxel, as well as radiation therapy. Those who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine, or to continue gemcitabine plus nab-paclitaxel. Morristown Medical Center is the only location in New Jersey offering this study. The study is sponsored by RenovoRx. NCT03257033
• 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 gemcitabine and nab-paclitaxel. This study, designed by Dr. Alistar, is funded by Raphael Pharmaceuticals, Inc. and Atlantic Health System. The study is designed for patients with locally advanced or metastatic pancreatic cancer who have never been treated with systemic chemotherapy. Atlantic Health System Cancer Care is the only cancer program in the nation to offer this promising study, at both Morristown and Overlook Medical Centers. Alistar led previous studies of this promising drug, which have been presented at major international scientific meetings and published in The Lancet Oncology. NCT03435289
• An SU2C Catalyst^® Randomized Phase 2 Trial of the PD1 Inhibitor Pembrolizumab With or Without a Vitamin D Receptor Agonist Paricalcitol in Patients With Stage IV Pancreatic Cancer Who Have Been Placed in the 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 to patients. This study will determine the effects of one possible maintenance regimen. The study is being conducted to determine the effects that pembrolizumab (Keytruda^Ò, a monoclonal antibody) with or without the addition of paricalcitol (synthetic Vitamin D) may have on pancreatic cancer. Half of the patients will be randomized to receive pembrolizumab plus paricalcitol and half to receive pembrolizumab plus placebo. This study is sponsored by The Translational Genomics Research Institute (TGen), in collaboration with Stand Up 2 Cancer and Merck. NCT03331562
• Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas. The purpose of this Phase 3 clinical trial is to examine the efficacy and safety of chemotherapy combination FOLFIRINOX (FFX) administered with experimental drug CPI-613, compared with modified FOLFIRINOX (mFFX) combined with CPI-613 for patients with pancreatic cancer that has metastasized. This trial is open label, and participants will be randomized to one of the two treatment groups. The study is sponsored by Raphael Pharmaceuticals, Inc. NCT03504423

• A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma. The Phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in participants with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). The study is sponsored by Genentech, Inc. NCT03193190

Each study has specific criteria for participation. To learn more, visit www.atlantichealth.org/research.