Ongoing Clinical Trials Actively Recruiting Patients  With Pancreatic Cancer

The information in this Clinical Trials Resource Guide includes details of actively recruiting clinical studies of patients with pancreatic cancer. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov. The studies presented here are nonrandomized, randomized, and interventional and include phase I and phase II clinical trials.

Study Type: Phase II/interventional/single-group assignment

Study Title: Phase II Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

Study Sponsor and Collaborators: Yale University

Purpose: The primary goal of this study is to determine the progression-free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable nonmetastatic pancreatic cancer treated with a dose-attenuated modification of leucovorin, fluorouracil, irinotecan, and oxaliplatin.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Progression-free survival (time frame: 24 weeks)

Principal Investigator: Jill Lacy, MD, Associate Professor of Medicine, Yale University. Contact: Jill Lacy, MD, 203-737-1600, jill.lacy@yale.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01523457

Study Title: A Pharmacodynamic Study of Metforim in Patients With Resectable Pancreatic Cancer

Study Sponsor and Collaborators: Case Comprehensive Cancer Center; National Cancer Institute

Purpose: To study metforim hydrochloride in treating patients with pancreatic cancer that can be removed by surgery. Metforim hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Pancreatic tumor cell proliferation and apoptosis as measured by the percentage of cells Ki-67–positive, percentage of cells TUNEL-positive, and mitotic counts in tissue samples (time frame: at time of surgery after 7 days of metformin treatment)

Principal Investigator: Neal J. Meropol, MD, Associate Director for Clinical Research, Case Comprehensive Cancer Center. Contact: Neal J. Meropol, MD, 216-844-5220, neal.meropol@uhhospitals.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01954732

Study Title: A Phase II Study of Induction Consolidation and Maintenance Approach for Patients With Advanced Pancreatic Cancer

Study Sponsor and Collaborators: Pancreatic Cancer Research Team

Purpose: The study investigators have developed a therapeutic regimen that attacks both the tumor compartment and the stromal compartment of pancreatic cancer and induces complete responses in a small percentage of patients with advanced stage IV pancreatic cancer. The induction regimen (gemcitabine plus nab-paclitaxel [Abraxane]) collapses the stroma and addresses the use of a non–cross-resistant active regimen (FOLFIRINOX [fluorouracil, leucovorin, irinotecan, oxaliplatin]) as a consolidation regimen. Both should improve the chance of driving tumor markers down dramatically. The investigators think that FOLFIRINOX with the stromal collapse induced by the initial regimen, plus the non–cross-resistant shot against the disease will maximize the change of achieving a complete response with an attendant improvement in survival

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Complete response rate (time frame: 1 year)

Principal Investigator: Ramesh K. Ramanathan, MD, Medical Director of the Virginia G. Piper Cancer Center Clinical Trials Program at Scottsdale Healthcare. Contact: Amy Stoll-D’Astice, MS, CCRP, 602-358-8319, astoll@td2inc.com

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01488552

Study Title: The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer

Study Sponsor and Collaborators: OHSU Knight Cancer Institute; National Cancer Institute

Purpose: To study an imaging technique known as dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in identifying the presence of pancreatic cancer. DCE-MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field and radio frequency pulses. These pictures may help identify underlying malignancy in patients at high risk or active malignancy in patients who have undergone chemotherapy for pancreatic cancer.

Ages Eligible for Study: 18 to 85 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: The presence of pancreatic cancer (time frame: up to 4 years)

Principal Investigator: Erin Gilbert, MD, Assistant Professor of Surgery, Oregon Health & Science University. Contact: Erin Gilbert, MD, 503-494-6900, gilberte@ohsu.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02070705

Study Title: A Pilot Study to Test the Feasibility of the Combination of Gemcitabine and Anti-PD1 Monoclonal Antibody (CT-011) in the Treatment of Resected Pancreatic Cancer

Study Sponsor and Collaborators: Georgia Regents University

Purpose: To test the safety and effectiveness of chemotherapy drugs gemcitabine and CT-011 as a follow-up treatment for pancreatic cancer that has been surgically removed

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To determine the feasibility and safety of the combination of CT-011 and gemcitabine in patients after primary macroscopic resection of pancreatic adenocarcinoma (time frame: 2 years)

 Principal Investigator: Samir N. Khleif, MD, Director, Georgia Regents University Cancer Center. Contact: Robin Dobbins, RN, 706-721-2154, rdobbins@gru.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01313416

Study Title: A Phase I Trial of Dinaciclib (SCH727965) and MK-2206 in Metastatic Pancreatic Cancer With an Expansion Cohort in Advanced Pancreatic Cancer

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and best dose of dinaciclib and Akt inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by surgery. Dinaciclib and MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: MTD of dinaciclib in combination with Akt inhibitor MK2206 defined as the highest dose at which 0 or 1 dose-limiting toxicities are observed in six patients (time frame: 28 days)

Principal Investigator: Nilofer S. Azad, MD, Assistant Professor of Oncology, Johns Hopkins/Sidney Kimmel Cancer Center. Contact: Nilofer S. Azad 410-614-9169 nazad2@jhmi.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01783171 ■