The study is being run by a team of dedicated physicians and researchers, led by Richard Frank, MD, Director of Clinical Cancer Research at the WCHN. The trial will include individuals with a strong family history of pancreatic cancer as well as those with new-onset diabetes mellitus (diagnosed within the past year). Participants will undergo annual high-resolution MRI examinations of the pancreas for three years. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS). If pancreatic cancer or a pre-cancerous lesion is identified, the individual will be referred for surgery. 

In an effort to determine a blood-based diagnostic test for the presence of early stage pancreatic cancer, study participants will be asked to donate a sample of blood every six month for three years. Such a test or “biomarker” would ultimately be used to determine which individuals are at high risk of PC and should undergo regular screening with MRI or EUS.

We will cover the costs of MRI examinations and other study related costs through philanthropic donations. Funding for this $2.7 million initiative depends on philanthropic support from individuals, corporations and foundations interested in finding an early detection for this lethal disease. To learn more about how you can support this study; please call (203) 852-2216 or (203) 739-7227.

*Actively Recruiting* (as of May 2020)

Individuals between 50-80 years of age who have developed diabetes mellitus within the preceding year will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research nurse and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed annually for 2 years (3 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant.

For more information, please contact: Tammy Lo, APRN (203) 822-3551 or Tammy.Lo@wchn.org  

Sponsor: Memorial Sloan Kettering Cancer Center

Number: MSK 16-1066

In this study, patients with advanced pancreatic cancer will receive gemcitabine, nab-paclitaxel, and PEGPH20 along with the drug rivaroxaban. This medication is used to reduce the risk of blood clots. It is a pill that is taken orally (by mouth); gemcitabine, nab-paclitaxel, and PEGPH20 are given intravenously (by vein). Researchers hope that the three anticancer drugs will shrink pancreatic tumors and that the addition of rivaroxaban (evaluated here at two different doses) will lower the chance of developing a blood clot during treatment.

A prior study of gemcitabine, nab-paclitaxel, and PEGPH20 showed that patients receiving this treatment had an increased risk of blood clots.

Who’s eligible:

Patients must have inoperable (stage III) or metastatic (stage IV) adenocarcinoma of the pancreas.

No prior treatment is permitted for stage III disease. Patients with metastatic cancer may have received previous treatment with gemcitabine or 5-FU for non-metastatic cancer, with at least 6 months passing between the completion of therapy and entry into the study.

Available at: The Hospital of Central Connecticut, MidState Medical Center, Backus Hospital- Eastern Connecticut Hematology and Oncology, and Hartford Hospital.

The purpose of this study is to evaluate the efficacy of modified FOLFIRINOX followed by stereotactic body radiotherapy (SBRT) in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). The primary hypothesis will be to determine if modified FOLFIRINOX followed by SBRT improves progression free survival (PFS) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.

For more information, please contact: Kimberly Johung, MD, PhD (203) 737-6876 kimberly.johung@yale.edu 

This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with gemcitabine plus nab-paclitaxel (G/NP) in the treatment of locally advanced, unresectable pancreatic cancer subjects.

Subjects will be randomized in a 1:1 ratio to one of the two study treatment arms; pamrevlumab with G/NP or placebo with G/NP.

Each subject may receive up to six cycles of treatment (each treatment cycle is 28 days). Tumor tissue will be collected during resection to determine surgical outcome and for biomarker analysis. Tumor response will be evaluated by changes in CT scan, FDG-PET, CA 19-9, and NCCN® guidelines.

All subjects randomized will have a safety follow-up visit approximately 28 days after the last dose of study treatment.

Subjects who complete 6 cycles of treatment will be evaluated for surgical exploration for possible R0 or R1 resection. Surgery will occur at least 4 weeks after the last dose (allowing for a wash-out period from treatment) and only after receipt of the recommendation from the central review board with regards to surgical eligibility. Surgery will occur no longer than 8 weeks after the last dose. Subjects who undergo surgery will be evaluated for surgical complications for at least an additional 90 days following discharge from surgery.

Subjects who are ineligible for surgical exploration (i.e. subjects who did not complete 6 cycles of treatment or do not meet any of the protocol defined criteria or had a contraindication to surgery) will continue in the Follow-up period and receive treatment as per standard of care (SOC) for each institution.

All subjects will be followed for disease progression (if not previously detected) or recurrence following resection (local progression or metastatic disease). Subjects will also be followed for any additional anti-cancer therapy received for their pancreatic cancer. All subjects will be followed for survival (until death) or until the last subject to complete treatment reaches 18 months post-treatment.

Yale New Haven Hospital Principal Investigator: Jill Lacy, MD 

The treatment period consists of 6 cycles. Cycles 1 and 2 involve the regional administration of oxaliplatin via PEDD-PRVI with systemic FOLFIRI. During cycles 1 and 2, patients are evaluated on days 1, 2, 4, and 8. Cycles 3 through 6 include the systemic administration of standard of care FOLFIRINOX. During cycles 3 through 6, patients are evaluated on days 1 and 8.

For more information, please contact: Kimberly Enos (401) 456-6472 or kimberly.enos@chartercare.org