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Brief Title: Phase 2 Study to Assess the Efficacy & Safety of Gemcitabine + Nab Paclitaxel With or Without Dociparstat in Metastatic Pancreatic Cancer Patients
Official Title: A Randomized Phase II Open Label Study to Assess the Efficacy & Safety of Gemcitabine + Abraxane® With or Without ODSH (2-0, 3-0 Desulfated Heparin) as First Line Treatment of Metastatic Pancreatic Cancer
Study ID: NCT01461915
Brief Summary: This randomized, Phase 2, open label study aims to assess the efficacy and safety of gemcitabine + nab paclitaxel with or without dociparstat (ODSH) as first line treatment of metastatic pancreatic cancer. This study consists of 2 periods: a Run-in Period and a Randomized Period.
Detailed Description: Dociparstat (ODSH) has demonstrated in vitro and in vivo inhibitory activity on mechanisms that are believed to play important roles in pancreatic cancer invasion, metastasis, and resistance to chemotherapy and radiation. Pancreatic cancer appears to have a dependence on autophagy, a regulated catabolic pathway to degrade and recycle cellular organelles and macromolecules. Autophagy appears to be largely driven by the binding of high mobility group box-1 protein (HMGB1) to the receptor for advanced glycation end-products (RAGE), which is strongly inhibited by dociparstat. Autophagy appears to not only assist pancreatic cancer cells to survive in a hypoxic, relatively avascular environment, but also appears to play an important role in chemotherapy resistance. Other important biological activities promoting pancreatic cancer invasion and metastasis affected by dociparstat include the inhibition of heparanase and the binding of tumor cells to endothelium and platelets mediated by the selectins. It is believed that these biological activities such as the inhibition of RAGE, heparanase, and selectin-mediated metastasis, can be inhibited by dociparstat at dose levels that can safely be administered without clinically significant anticoagulation. The standard of care of pancreatic cancer is evolving. It appears that 2 combination regimens, the "FOLFIRINOX" regimen (a combination of 5-fluorouracil, leucovorin, irinotecan and oxaliplatin) and the combination of gemcitabine + nab-paclitaxel, could have more activity than the previous standard treatment of gemcitabine alone. Patients with advanced metastatic pancreatic cancer who have not received chemotherapy, surgical or radiation treatments and have a good performance status are eligible to participate in this study. This study consists of 2 periods: a Run-in Period and a Randomized Period. In total, 10 patients are planned to be enrolled in a Run-in Period to receive gemcitabine + nab-paclitaxel + dociparstat. Pharmacokinetic sampling and safety assessments are to be conducted to decide on the continuation to the Randomized Period of the study where 50 patients are planned to be randomized at a 1:1 ratio to either of the 2 study arms: * Arm A: Patients will receive gemcitabine + nab-paclitaxel + dociparstat * Arm B: Patients will receive gemcitabine + nab-paclitaxel The primary endpoint of this study is mean progression free survival. The secondary endpoints of this study are to consist of tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, overall survival at the end of the study, and changes from baseline for carbohydrate antigen (CA) 19-9 marker, weight, and plasma albumin.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Scottsdale, Arizona, United States
Disney Family Cancer Center, Burbank, California, United States
Marin Cancer Care, Greenbrae, California, United States
Scripps Clinic Torrey Pines ( Green Hospital), La Jolla, California, United States
Cleveland Clinic Florida, Weston, Florida, United States
Loyola University Medical Center/Cardinal Bernardin Cancer Center, Maywood, Illinois, United States
Indiana University Health, Goshen Center for Cancer Care, Goshen, Indiana, United States
Fesit-Weiller Cancer Center, Shreveport, Louisiana, United States
Saint Mary's Health Care, Grand Rapids, Michigan, United States
Summa Health System - Cooper Cancer Center, Akron, Ohio, United States
Thomas Jefferson University [Kimmel Cancer Center], Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina, United States
University of Texas Medical Branch, Galveston, Texas, United States
South Texas Oncology & Hematology, San Antonio, Texas, United States
Name: Mitesh J Borad, MD
Affiliation: Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic , Scottsdale Arizona
Role: PRINCIPAL_INVESTIGATOR
Name: Stephen Marcus, MD
Affiliation: ParinGenix Inc, Weston FL
Role: STUDY_DIRECTOR