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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT03883919
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-FU — DRUG
    -Standard of care drug
  • Leucovorin — DRUG
    -Standard of care drug
  • Liposomal Irinotecan — DRUG
    -Standard of care drug
  • Paricalcitol — DRUG
    -Investigational drug
  • Serum and plasma blood samples — PROCEDURE
    -baseline, day 1 of each cycle beginning with cycle 2
  • Tumor biopsy — PROCEDURE
    * 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.

Study Details

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.

Key Dates

Start date
Jul 11, 2019
Status verified
Oct 2022
Primary completion
Mar 23, 2021
Completion
Jul 2, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Paricalcitol 75 mcg Days 1 and 8
    * 5-FU, LV, and nal-IRI will be administered at standard fixed doses. Briefly, 5-FU will be given at a dose of 2400 mg/m\^2 continuous IV infusion over 46 hours, LV will be given at 400 mg/m\^2 IV over 30 minutes, and liposomal irinotecan will be given at a dose of 70 mg/m\^2 IV over 90 minutes (unless homozygous for the UGT1A1\*28 7/7 allele, in which case the dose will start at 50 mg/m\^2 and escalate to 70 mg/m\^2 in subsequent cycles if no excessive toxicity is experienced) on Day 1 of each 14-day cycle. * Paricalcitol 75 mcg on Days 1 and 8 * Treatment with liposomal irinotecan plus 5FU/ LV may continue indefinitely, and treatment with paricalcitol may continue for up to 10 cycles (20 weeks)
  • Experimental: Group 2: Paricalcitol 7 mcg/kg Days 1 and 8
    * 5-FU, LV, and nal-IRI will be administered at standard fixed doses. Briefly, 5-FU will be given at a dose of 2400 mg/m\^2 continuous IV infusion over 46 hours, LV will be given at 400 mg/m\^2 IV over 30 minutes, and liposomal irinotecan will be given at a dose of 70 mg/m\^2 IV over 90 minutes (unless homozygous for the UGT1A1\*28 7/7 allele, in which case the dose will start at 50 mg/m\^2 and escalate to 70 mg/m\^2 in subsequent cycles if no excessive toxicity is experienced) on Day 1 of each 14-day cycle. * Paricalcitol 7 mcg/kg on Days 1 and 8 * Treatment with liposomal irinotecan plus 5FU/ LV may continue indefinitely, and treatment with paricalcitol may continue for up to 10 cycles (20 weeks)

Primary Outcome Measure

Tolerability between two different dose levels of paricalcitol added to the combo regimen of liposomal irinotecan plus 5-FU / LV as measured by the occurrence of grade 3 and 4 toxicities [ Time Frame: Through 30 days after completion of paricalcitol treatment (estimated to be 28 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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