Clinical Trials Actively Recruiting Patients With Pancreatic Cancer

Study Type: Pilot/interventional/single-group assignment

Study Title: Preoperative Rehabilitation During Neoadjuvant Therapy for Pancreatic Cancer: A Pilot Study

Study Sponsor and Collaborators: MD Anderson Cancer Center

Purpose: To learn if it is possible to start a home-based exercise and nutrition program for patients with pancreatic cancer or who may have pancreatic cancer before surgery (preoperative rehabilitation, also known as prehabilitation)

Primary Outcome Measures: Feasibility of prehabilitation program among patients [time frame: 6 weeks]

Principal Investigator: Matthew H. Katz, MD, MD Anderson Cancer Center; 713-794-4660

For more information: Use ClinicalTrials.gov Identifier NCT02295956

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

Study Title: Pilot Study of Autologous T Cells Redirected to Mesothelin and CD19 With a Chimeric Antigen Receptor in Patients With Metastatic Pancreatic Cancer

Study Sponsor and Collaborators: University of Pennsylvania, University of California, San Francisco

Purpose: To learn if the combination therapy of CART-meso cells and CART19 cells administered at 3 days after one dose of cyclophosphamide may prolong the duration of CART-meso cells in the body

Primary Outcome Measures: Safety of IV administration of CART-meso-19 with cyclophosphamide as lymphodepleting chemotherapy in patients with pancreatic cancer using the NCI CTCAE v4.03 criteria [time frame: 24 months]

Principal Investigator: Andrew Ko, MD, University of California, San Francisco; contact Elizabeth Dito, RN, 415-353-7244, elizabeth.dito@ucsf.edu

For more information: Use ClinicalTrials.gov Identifier NCT02465983

Study Title: A Phase I Study of BKM120 With mFOLFOX6 in Patients With Advanced Solid Tumors With Expansion Cohort in Metastatic Pancreatic Cancers

Study Sponsor and Collaborators: UNC Lineberger Comprehensive Cancer Center

Purpose: To establish the safety and tolerability of BKM120 when combined with mFOLFOX6 and to define the maximum tolerated dose of BKM120 in this combination in advanced solid tumors including metastatic pancreatic cancer

Primary Outcome Measures: Dose-limiting toxicity [time frame: 3 years]; maximum tolerated dose [time frame: 3 years]

Principal Investigator: Autumn McRee, MD, UNC Lineberger Comprehensive Cancer Center; contact Julie White, RN, 919-966-7112, julie_white@med.unc.edu

For more information: Use ClinicalTrials.gov Identifier NCT01571024

Study Type: Phase II/interventional/Parallel Assignment

Study Title: Phase II Study of Preoperative FOLFIRINOX vs Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

Study Sponsor and Collaborators: Massachusetts General Hospital

Purpose: To evaluate a combination of drugs, FOLFIRINOX and gemcitabine/nab-paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery

Primary Outcome Measures: Survival rate at 18 months [time frame: 18 months]

Principal Investigator: David Patrick Ryan, MD, Massachusetts General Hospital; 617-724-4000, dpryan@partners.org

For more information: Use ClinicalTrials.gov Identifier NCT02243007

Study Title: MR-Guided Phase II Radiotherapy Dose Escalation in Unresectable Nonmetastatic Pancreatic Cancer

Study Sponsor and Collaborators: Medical College of Wisconsin

Purpose: To evaluate if an imaging-guided dose of escalated radiotherapy and concurrent chemotherapy in unresectable pancreatic cancer can control the spread of disease

Primary Outcome Measures: To evaluate the efficacy of dose escalation to an MR-defined GTV of up to 69.75 Gy at 2.25 Gy per fraction for unresectable pancreatic cancer [time frame: 1 year from the start of treatment ]

Principal Investigator: Beth Erickson, MD, Froedtert & The Medical College of Wisconsin; contact Cancer Center Clinical Trials Office, 1-800-680-0505 ext 8900, ccto@mcw.edu

For more information: Use ClinicalTrials.gov Identifier NCT01972919

Study Type: Phase II/III/interventional/parallel assignment

Study Title: Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma

Study Sponsor and Collaborators: Columbia University

Purpose: To assess the safety and benefit of six 3-week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (GTX)

Primary Outcome Measures: To determine the effect of neoadjuvant regimen of GTX on the 2-year disease-free survival rate [time frame: 2 years]

Principal Investigator: William Sherman, MD, Columbia University; contact Kyung Chu, RN, 212-305-9467, kc2113@columbia.edu

For more information: Use ClinicalTrials.gov Identifier NCT01065870

Study Type: Phase III/interventional/parallel assignment

Study Title: A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer

Study Sponsor and Collaborators: Stanford University

Purpose: To determine the safety and efficacy of a chemotherapy regimen known as mFFX alone or with the addition of SBRT.

Primary Outcome Measures: Difference in progression-free survival between mFOLFIRINOX alone vs mFOLFIRINOX and SBRT [time frame: 1 year]

Principal Investigator: Albert Koong, PhD, Stanford University; contact Rachel Freiberg, PhD, 650-725-0438, rachelf@stanford.edu

For more information: Use ClinicalTrials.gov Identifier NCT01926197

Study Type: Phase IV/interventional/parallel assignment

Study Title: Comparison Study in Pancreatic Fiducial Placement

Study Sponsor and Collaborators: Parkview Health

Purpose: To compare 19-gauge EUS FNA BNX needle vs 22-gauge EUS FNA BNX needle in pancreatic fiducial placement to treat pancreatic cancer

Primary Outcome Measures: Total cost comparison [time frame: duration of fiducial placement procedure; approximately 30 minutes]; total time comparison [time frame: duration of fiducial placement procedure; up to 30 minutes]

Principal Investigator: Neil ­Sharma, MD, Parkview Health; 260-266-5230, neil.sharma@parview.com

For more information: Use ClinicalTrials.gov Identifier NCT02376543

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov. ■