A Study Of Neoadjuvant Paricalcitol To Target The Microenvironment In Resectable Pancreatic Cancer

Study Overview

A Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

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.

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.

Adenocarcinoma of the Pancreas

DRUG: Paricalcitol
DRUG: Abraxane
DRUG: Gemcitabine

UPCC 23213

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-01-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-22
First Submitted that Met QC Criteria 2014-01-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-25
First Posted (ACTUAL) 2014-01-09	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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	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 p DRUG: Abraxane Dose: 125mg/m2 Route: IV infusion over 30 minutes Frequency (within a 28 day cycle): Day 1, 8, 15 DRUG: Gemcitabine Dose: 1000mg/m2 Route: IV infusion over 30-100 minutes Frequency (within a 28 day cycle): Day 1, 8, 15
ACTIVE_COMPARATOR: No Pre-operative Paricalcitol Subject will receive gemcitabine/abraxane without paricalcitol preoperatively.	DRUG: Abraxane Dose: 125mg/m2 Route: IV infusion over 30 minutes Frequency (within a 28 day cycle): Day 1, 8, 15 DRUG: Gemcitabine Dose: 1000mg/m2 Route: IV infusion over 30-100 minutes Frequency (within a 28 day cycle): Day 1, 8, 15

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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

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 p

DRUG: Abraxane

Dose: 125mg/m2 Route: IV infusion over 30 minutes Frequency (within a 28 day cycle): Day 1, 8, 15

DRUG: Gemcitabine

Dose: 1000mg/m2 Route: IV infusion over 30-100 minutes Frequency (within a 28 day cycle): Day 1, 8, 15

ACTIVE_COMPARATOR: No Pre-operative Paricalcitol

Subject will receive gemcitabine/abraxane without paricalcitol preoperatively.

DRUG: Abraxane

Dose: 125mg/m2 Route: IV infusion over 30 minutes Frequency (within a 28 day cycle): Day 1, 8, 15

DRUG: Gemcitabine

Dose: 1000mg/m2 Route: IV infusion over 30-100 minutes Frequency (within a 28 day cycle): Day 1, 8, 15

Primary Outcome Measures	Measure Description	Time Frame
Number of Adverse Events	number of adverse events in 2years	2 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Peter O'Dwyer, MD, Abramson Cancer Center at Penn Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record