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FOLFIRINOX + Digoxin for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior chemotherapy for pancreatic cancer
Pathologically confirmed adenocarcinoma of the pancreas with resectable disease and no evidence of distant metastasis
Must not have
Patients unable to undergo staging laparoscopy due to prior history of multiple abdominal operations
Contra-indication to receiving digoxin therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs for pancreatic cancer that may be more effective and have fewer side effects than current treatment.

Who is the study for?
This trial is for adults (19+) with resectable pancreatic cancer, no distant metastasis, and good performance status. They must have normal organ function, not received prior treatment for pancreatic cancer, and be disease-free from other cancers for 5+ years. Pregnant women or those with certain health conditions like heart failure or active infections cannot participate.
What is being tested?
The study tests the safety and effectiveness of adding digoxin to FOLFIRINOX chemotherapy in treating resectable pancreatic cancer. Digoxin is being investigated for its potential to affect the hypoxia pathway which might improve treatment outcomes.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk; plus specific ones related to digoxin like changes in heart rhythm and levels of electrolytes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had chemotherapy for pancreatic cancer.
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My pancreatic cancer is confirmed and can be surgically removed without spread.
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I am fully active or can carry out light work.
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I am 19 years old or older.
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My kidney function is normal, with creatinine ≤ 2.0 mg/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have a laparoscopy due to many past abdominal surgeries.
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I cannot take digoxin due to health reasons.
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I do not have any serious ongoing illnesses like heart failure or uncontrolled infections.
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I have a known immune system disorder.
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I have HIV or active hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients able to undergo resection surgery
Secondary study objectives
Percentage of subjects with grade 4 thrombocytopenia and grade 3-4 diarrhea

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5Fluorouracil
2020
Completed Phase 3
~900
Irinotecan
2017
Completed Phase 3
~2590
Digoxin
2017
Completed Phase 4
~670
Oxaliplatin
2011
Completed Phase 4
~2890

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,353 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,049 Total Patients Enrolled
Jean Grem, MDLead Sponsor

Media Library

5Fluorouracil (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04141995 — Phase 2
Pancreatic Cancer Research Study Groups: Treatment
Pancreatic Cancer Clinical Trial 2023: 5Fluorouracil Highlights & Side Effects. Trial Name: NCT04141995 — Phase 2
5Fluorouracil (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04141995 — Phase 2
~0 spots leftby Feb 2025