FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT04141995
Phase
PHASE2
Status
Terminated

Conditions

  • Adenocarcinoma of the Pancreas
  • Pancreas Cancer

Eligibility Criteria

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

Interventions

  • Digoxin — DRUG
    Tablet, Oral: Generic: 0.125 mg, 0.25 mg
  • 5Fluorouracil — DRUG
    5-FU will be given as a 46 hour continuous IV infusion
  • Calcium Leucovorin — DRUG
    IV injection over 90 minutes
  • Irinotecan — DRUG
    IV administration over 90 minutes
  • Oxaliplatin — DRUG
    IV administration

Study Details

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.

Key Dates

Start date
Feb 12, 2021
Status verified
Apr 2025
Primary completion
May 13, 2025
Completion
May 13, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Participants start FOLFIRINOX. They will also begin digoxin and take it up to 4-5 months time period in patients with resectable pancreatic cancer. Digoxin is taken at the time of neo-adjuvant chemotherapy treatment, prior to surgery. After surgery, participants will continue with post-adjuvant chemotherapy.

Primary Outcome Measure

Number of patients able to undergo resection surgery [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NE

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