FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

NCT04141995 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-08-07

No results posted yet for this study

Summary

The purpose of this study is to determine the feasibility and safety of combining digoxin as a modulator of the hypoxia pathway in combination with FOLinic acid, 5-Fluorouracil, IRINotecan and OXaliplatin (FOLFIRINOX) in participants with resectable pancreatic cancer.

Conditions

  • Pancreas Cancer
  • Adenocarcinoma of the Pancreas

Interventions

DRUG

Digoxin

Tablet, Oral: Generic: 0.125 mg, 0.25 mg

DRUG

5Fluorouracil

5-FU will be given as a 46 hour continuous IV infusion

DRUG

Calcium Leucovorin

IV injection over 90 minutes

DRUG

Irinotecan

IV administration over 90 minutes

DRUG

Oxaliplatin

IV administration

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Nebraska

    lead OTHER

Principal Investigators

  • Jean Grem, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2025-05-13
Completion
2025-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141995 on ClinicalTrials.gov