Yale Pancreas Disease Program Research

Early Detection of Pancreatic Cancer

The Cancer of the Pancreas Screening-5 (CAPS5) Study
The purpose of the study is to evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls; to compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance.
Principal Investigator: James Farrell, MD

Smilow Cancer Genetics and Prevention Research Repository
The purpose of this study is to create a Smilow Cancer Genetics and Prevention Program patient repository to collect data, tissue, blood and/or saliva that will be used for clinical follow-up as well as current and future research projects involving the study of hereditary cancer syndromes and related medical issues, such as those at increase risk of developing pancreatic cancer.
Principal Investigator: Erin Hofstatter, MD

Pancreatic Cystic Neoplasms

Evaluation of Pancreatic Cysts
To evaluate the manner in which patients with pancreatic cysts are being monitored and followed at Yale New Haven Hospital
Principal Investigator: James Farrell, MD

Yale GI Cancer Tissue Biorepository
The Gastrointestinal Cancer Biorepository, contains a library of blood samples, germline DNA, tumor samples, immortalized cell lines derived from surgically-resected gastrointestinal cancer tumors and important historical information regarding past medical events, family history and certain lifestyle choices such as smoking habits that may be related to the development of digestive tract cancers from all the people who agree to participate in this research project. The samples will then be available to all qualified gastrointestinal cancer doctors and researchers for their experiments, with the goal of improving the diagnosis and care of all gastrointestinal cancer patients and those with related conditions like benign pancreatic cysts
Principal Investigator: Howard Hochster, MD

Pancreatic Disease Endoscopic Research

A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device with a 20G EUS ProCore FIne Needle Biopsy (FNB) Device ASPRO trial (ASPiration versus PROcore)
The primary objective is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device in a variety of diseases including pancreatic masses and malignancy.
Principal Investigator: James Farrell, MD

Pancreatic Cancer Treatment

A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer
This is a randomized phase II multi-institution prospective open label study in which up to 90 subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who previously received treatment with chemotherapy with FOLFIRINOX or FOLFIRINOX-like regimen will be enrolled into one of two arms:A: NPC-1C with gemcitabine and nab-paclitaxel or B: gemcitabine and nab-paclitaxel
Principal Investigator: Jill Lacy, MD

Randomized Phase II Study of 2nd Line FOLFIRI Versus Modified FOLFIRI With PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer
This randomized phase II trial studies how well modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) and veliparib as a second line of therapy work compared to FOLFIRI in treating patients with pancreatic cancer that has come back after a period of improvement (metastatic). Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether modified FOLFIRI and veliparib as second line therapy is more effective than FOLFIRI alone in treating metastatic pancreatic cancer.
Principal Investigator: Jeremy Kortmansky

Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer
This phase II trial studies how well combination chemotherapy before and after surgery works in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Principal Investigator: Jill Lacy

S1313, Combination Chemotherapy With or Without PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
This partially randomized phase I/II trial studies the side effects and best dose of pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination chemotherapy and to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed pancreatic cancer that has spread to other places in the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without pegylated recombinant human hyaluronidase in treating pancreatic cancer.
Principal Investigator: Howard Hochster

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy Principal
Investigator: Howard Hochster

An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma
The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
Principal Investigator: Howard Hochster

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
To investigate the safety and efficacy of Nivolumab as a single agent or in combination with Ipilimumab in 4 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC).
Principal Investigator: Joseph Eder

An Open-Label, Multicenter Phase Ib Study of The Safety and Tolerability of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination With Bevacizumab And/Or Other Treatments in Patients With Solid Tumors
This study will evaluate the safety, tolerability and pharmacokinetic variability of atezolizumab, in combination with bevacizumab and/or Oxaliplatin, Leucovorin and 5-Fluorouracil (FOLFOX) at the dose level and schedule indicated for hepatocellular carcinoma (HCC) (Arm A) and gastric cancer (Arm B), and in combination with nab-paclitaxel and gemcitabine at the dose level and schedule indicated for metastatic pancreatic cancer (Arm C).
Principal Investigator: Howard Hochster

A Phase II Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
This phase II trial studies cediranib maleate in combination with olaparib in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery, including breast cancer, non-small cell lung cancer, small cell lung cancer, and pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.
Principal Investigator: Joseph Kim

Evaluation of Predictive and Prognostic Biomarkers in Pancreatic Disease
The underlying aim and purpose of this study is to assess tissue samples for biological and genetic information to predict outcome or response to therapy in pancreatic disease.
Principal Investigator: James Farrell, MD