Clinical trial · Interventional
FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer
A Phase IIa (Pilot) Study of Neoadjuvant Chemotherapy With Folinic Acid, 5-FU, Irinotecan and Oxaliplatin (FOLFIRINOX) With Digoxin in Patients With Resectable Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to low accrual and futility
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5Fluorouracil | Drug | — | UNRESOLVED |
| Calcium Leucovorin | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| Digoxin | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- 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.
- interventionNames
- Drug: Digoxin
- Drug: 5Fluorouracil
- Drug: Calcium Leucovorin
- Drug: Irinotecan
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Number of patients able to undergo resection surgery
- timeFrame
- 16 weeks
- description
- Regimen will be considered for further investigation if 14 of the 20 patients are able to undergo resection
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed pancreatic adenocarcinoma. Participants must have resectable disease with no evidence of distant metastasis. * 19 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. Exclusion Criteria: * 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.
References
Publications (0)
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