A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in 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.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of the Pancreas
• Intervention / Treatment: Drug: Paricalcitol; Drug: Abraxane; Drug: Gemcitabine

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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 until the day before surgery (+/- 3 days).	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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	2 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Peter O'Dwyer, MD, Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimated): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Albumin-Bound Paclitaxel; Gemcitabine
• Other Study ID Numbers: UPCC 23213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No