A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Number of Adverse Events
time frame: 2 years
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
|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|
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