A Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
NCT02030860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-07-25
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.
Conditions
- Adenocarcinoma of the Pancreas
Interventions
- DRUG
-
Paricalcitol
Dose: 25 micrograms Route: IV Frequency (within a 28 day cycle):Three times weekly for one cycle beginning day 1 of therapy until the day before surgery (+/- 3 days) (for subjects randomized to receive paricalcitol), then three times weekly for 3 cycles post-operatively (for all subjects).
- DRUG
-
Dose: 125mg/m2 Route: IV infusion over 30 minutes Frequency (within a 28 day cycle): Day 1, 8, 15
- DRUG
-
Dose: 1000mg/m2 Route: IV infusion over 30-100 minutes Frequency (within a 28 day cycle): Day 1, 8, 15
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Peter O'Dwyer, MD · Abramson Cancer Center at Penn Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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