A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Overview
- Phase
- Phase 1
- Intervention
- Paricalcitol
- Conditions
- Adenocarcinoma of the Pancreas
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of Adverse Events
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Pre-operative Paricalcitol
Subject will receive gemcitabine/abraxane with preoperatively paricalcitol. Patients randomized to receive paricalcitol pre-operatively will begin treatment with intravenous paricalcitol at 25 μg three times weekly for one cycle beginning day 1 of therapy until the day before surgery (+/- 3 days).
Intervention: Paricalcitol
Pre-operative Paricalcitol
Subject will receive gemcitabine/abraxane with preoperatively paricalcitol. Patients randomized to receive paricalcitol pre-operatively will begin treatment with intravenous paricalcitol at 25 μg three times weekly for one cycle beginning day 1 of therapy until the day before surgery (+/- 3 days).
Intervention: Abraxane
Pre-operative Paricalcitol
Subject will receive gemcitabine/abraxane with preoperatively paricalcitol. Patients randomized to receive paricalcitol pre-operatively will begin treatment with intravenous paricalcitol at 25 μg three times weekly for one cycle beginning day 1 of therapy until the day before surgery (+/- 3 days).
Intervention: Gemcitabine
No Pre-operative Paricalcitol
Subject will receive gemcitabine/abraxane without paricalcitol preoperatively.
Intervention: Abraxane
No Pre-operative Paricalcitol
Subject will receive gemcitabine/abraxane without paricalcitol preoperatively.
Intervention: Gemcitabine
Outcomes
Primary Outcomes
Number of Adverse Events
Time Frame: 2 years
number of adverse events in 2years