This phase Ib trial studies how well paricalcitol before primary treatment works in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as paricalcitol, 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03300921.
PRIMARY OBJECTIVES:
I. To determine the effect of neoadjuvant targeting of the immune microenvironment with vitamin D in patients with resectable pancreatic cancer through an assessment of genetic, immunologic, and histologic markers.
SECONDARY OBJECTIVES:
I. To determine the safety of two dosing regimens of paricalcitol in the pre-operative setting.
II. To analyze the effects of paricalcitol on cytokine expression.
III. To determine the effects of genomic alterations on the tumor and stellate cell response to vitamin D.
IV. To analyze the effects of paricalcitol on tumor metabolism.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: Patients receive paricalcitol intravenously (IV) once weekly until the day prior to surgery.
ARM B: Patients receive paricalcitol orally (PO) once daily (QD) days until the day prior to surgery.
After completion of study treatment, patients are followed up every 6 months for 1 year, then annually for 2 years.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorPeter James O'Dwyer
