A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Albumin-Bound Paclitaxel; Ergocalciferols; Gemcitabine

Criteria

Inclusion Criteria

• Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.

• Age greater than or equal to 18 years

• Eastern Cooperative Oncology Group 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 < 2x Upper Normal Limit , Transaminases < 3x Upper Normal Limit, 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