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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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