NCT03883919

Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy

A Pilot Study of Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Given the efficacy of nanoliposomal irinotecan as a second-line regimen in pancreatic ductal adenocarcinoma (PDAC), together with the favorable toxicity profile of paricalcitol and its interplay with irinotecan metabolism, the investigators propose a second-line pilot study in advanced PDAC that will enroll patients who have progressed on a gemcitabine-based regimen.

Conditions

• Pancreatic Cancer
• Pancreas Cancer
• Cancer of the Pancreas

Interventions

Type	Name	Description
DRUG	5-FU	-Standard of care drug
DRUG	Leucovorin	-Standard of care drug
DRUG	Liposomal Irinotecan	-Standard of care drug
DRUG	Paricalcitol	-Investigational drug
PROCEDURE	Serum and plasma blood samples	-baseline, day 1 of each cycle beginning with cycle 2
PROCEDURE	Tumor biopsy	* 5 patients in each arm will be required to undergo a mandatory tumor biopsy from the primary pancreatic site or metastatic site, if safe and feasible, prior to cycle 1 * After Cycle 3 of treatment, all patients who had a baseline biopsy will be required to undergo a mandatory biopsy of the same site if safe and feasible.

Timeline

• Start date: 2019-07-11
• Primary completion: 2021-03-23
• Completion: 2022-07-02
• First posted: 2019-03-21
• Last updated: 2022-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study