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FOLFIRINOX + Digoxin for Pancreatic Cancer

Phase 2

Recruiting

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be aware of the neoplastic nature of the disease and provide written, informed consent

No prior chemotherapy for pancreatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 understand my disease is cancerous and I have given written consent.

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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 had chemotherapy for a cancer other than pancreatic over 5 years ago and am now cancer-free.

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients able to undergo resection surgery

Secondary outcome measures

Percentage of subjects with grade 4 thrombocytopenia and grade 3-4 diarrhea

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 4

~2680

Digoxin

2017

Completed Phase 4

~670

Oxaliplatin

2011

Completed Phase 4

~2560

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor

537 Previous Clinical Trials

1,143,934 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,647 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what types of cases is 5Fluorouracil typically administered?

"5-Fluorouracil is a common treatment for small cell lung cancer (sclc) and has also been used to treat joint pain, rectal carcinoma, and colorectal carcinoma."

Answered by AI

How many participants have been recruited for this clinical experiment?

"Affirmative. Trials data publicly accessible on clinicaltrials.gov suggest that this experiment is still actively seeking volunteers, with the initial posting occuring on February 12th 2021 and the most recent update occurring March 31st 2022. The study requires 20 participants to be recruited from a single site."

Answered by AI

Are applications currently being accepted for the clinical trial?

"Affirmative. According to the clinicaltrials.gov record, this research project is actively recruiting participants; it was opened on February 12th 2021 and its last modification occurred on March 31st 2022. It requires 20 people from 1 site for completion."

Answered by AI

Could you elaborate on which other investigations have utilized 5Fluorouracil?

"Presently, 666 studies are being conducted to further understand 5Fluorouracil. Of those trials 207 have progressed to Phase 3 and these are predominantly based in Guangzhou, Guangdong. Additionally, the research is also taking place at 27690 other locations around the world."

Answered by AI