FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

NCT04141995 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: 0668-19-FB1P50CA127297-01A2
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Cancer; Adenocarcinoma of the Pancreas

Keywords

Resectable

Outcome Measures

Primary Outcomes (1)

• Number of patients able to undergo resection surgery

  Regimen will be considered for further investigation if 14 of the 20 patients are able to undergo resection

  16 weeks

Secondary Outcomes (1)

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

  16 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Drug: Digoxin; Drug: 5Fluorouracil; Drug: Calcium Leucovorin; Drug: Irinotecan; Drug: Oxaliplatin

Interventions

Digoxin DRUG

Tablet, Oral: Generic: 0.125 mg, 0.25 mg

Also known as: Lanoxin, Digitek, Digox

Treatment

5Fluorouracil DRUG

5-FU will be given as a 46 hour continuous IV infusion

Also known as: Adrucil, 5-FU

Treatment

Calcium Leucovorin DRUG

IV injection over 90 minutes

Also known as: Folinic Acid

Treatment

Irinotecan DRUG

IV administration over 90 minutes

Also known as: Camptothecin-11, CPT-11, Camptosar

Treatment

Oxaliplatin DRUG

IV administration

Also known as: Eloxatin

Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed pancreatic adenocarcinoma. Participants must have resectable disease with no evidence of distant metastasis.
• years of age or older.
• Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) of 0-1 (fully active to restricted in strenuous activity).
• Chemotherapy for malignancies other than pancreatic cancer completed \> 5 years ago and is no evidence of the prior malignancy at time of study entry.
• Radiographically assessable disease.
• Initial absolute neutrophil count (ANC) greater than or equal to 1000/μL and platelet count greater than or equal to 100,000/μL.
• Normal serum potassium, magnesium and corrected calcium level.
• Serum creatinine less than or equal to 2.0 mg/dL.
• Total bilirubin \<= 1.5 mg/dL \[unless the participant has Gilbert disease with elevated non-conjugated (indirect) bilirubin; in such cases, the indirect bilirubin should be \<= 1.0 mg/dL\].
• If participant has biliary obstruction, biliary decompression will be required. Either endoscopic placement of biliary stent or percutaneous transhepatic drainage are acceptable. Once biliary drainage has been established, institution of FOLFOX therapy may proceed when the total bilirubin falls to \<= 5.0 mg/dL. The addition of irinotecan will be delayed until the total bilirubin is 1.5 mg/dL or lower.
• Awareness of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
• No prior chemotherapy for pancreatic cancer.

You may not qualify if:

• Unable to undergo staging laparoscopy, such as a prior history of multiple abdominal operations in which laparoscopy may not be technically feasible or might be potentially harmful.
• A contra-indication to receiving digoxin therapy (e.g., AV block, sick sinus syndrome, bradycardia, hypersensitivity to digoxin or digitalis preparations).
• Uncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that might jeopardize the ability of the participant to receive the therapy in this study with reasonable safety.
• Pregnant and nursing women (risk posed by chemotherapy agents). Female participants of childbearing potential must have a negative urine pregnancy test before receiving the first dose of study drug.
• Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated non-invasive carcinomas, or other cancers from which the participant has been disease-free least 5 years.
• Known HIV infection or active hepatitis B or C infection (concern for increased toxicity).
• Active autoimmune disease \[e.g., rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), ulcerative colitis (UC), Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis (AS)\].
• Recognized acquired, hereditary, or congenital immunodeficiency disease including cellular immunodeficienciess, hypogammaglobulinemia, or dysgammaglobulinemia.

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Digoxin; Fluorouracil; Leucovorin; Irinotecan; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Coordination Complexes; Organic Chemicals

Study Officials

• Jean Grem, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 28, 2019
• Study Start: February 12, 2021
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)