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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
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
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 belowSelect...
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:Select...
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
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
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
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
544 Previous Clinical Trials
1,144,968 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,381 Total Patients Enrolled
Jean Grem, MDLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have a laparoscopy due to many past abdominal surgeries.I understand my disease is cancerous and I have given written consent.I cannot take digoxin due to health reasons.Your blood levels of potassium, magnesium, and calcium are within the normal range.I have not had chemotherapy for pancreatic cancer.I do not have any serious ongoing illnesses like heart failure or uncontrolled infections.My pancreatic cancer is confirmed and can be surgically removed without spread.Your white blood cell count is at least 1000/μL and your platelet count is at least 100,000/μL.Your total bilirubin levels should be less than 1.5 mg/dL, unless you have Gilbert disease with indirect bilirubin less than 1.0 mg/dL, or if you need treatment for bile duct blockage.I have a known immune system disorder.I had chemotherapy for a cancer other than pancreatic over 5 years ago and am now cancer-free.I have HIV or active hepatitis B or C.I am fully active or can carry out light work.You have an ongoing autoimmune disease.I am 19 years old or older.I have no cancer history in the last 5 years, except for certain skin cancers or noninvasive cancers that were treated.My kidney function is normal, with creatinine ≤ 2.0 mg/dL.You must have a disease that can be seen on a medical scan.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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