This trial is active, not recruiting.

Conditions subjects must have previously untreated apparently resectable adenocarcinoma, of the pancreas.
Treatments paricalcitol, abraxane, gemcitabine
Sponsor Abramson Cancer Center of the University of Pennsylvania
Start date January 2014
End date December 2015
Trial size 15 participants
Trial identifier NCT02030860, UPCC 23213


This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to target the microenvironment in resectable pancreatic cancer to determine the effect of targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic cancer through an assessment of cellular and imaging markers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Number of Adverse Events
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration. - Age greater than or equal to 18 years - ECOG performance status of 0-2. - Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the patient on the trial. Note: subjects must have: Creatinine < 2xULN, Transaminases < 3xULN, Neutrophils >1.5x109/L, and Platelets >100,000/mm3 - Ability to provide written informed consent Exclusion Criteria - Patients with hypercalcemia (blood levels greater than 11.5 mg/dL; in patients with kidney disease, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol). - Patients who are currently pregnant, planning to become pregnant, or breast-feeding. - Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation

Additional Information

Official title A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Principal investigator Peter O'Dwyer, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.