Due to low accrual and futility
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
Sponsor study identifier
Secondary identifiers
interventional
11
1 country
1
Study Start
February 12, 2021
Actual (reported)Primary Completion
May 13, 2025
Actual (reported)Study Completion
May 13, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 13, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2019
Actual (reported)October 28, 2019
Actual (reported)February 12, 2021
Actual (reported)May 13, 2025
Actual (reported)May 13, 2025
Actual (reported)October 21, 2026
Actual (reported)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
Number of Subjects With Grade 4 Thrombocytopenia and Grade 3-4 Diarrhea
16 weeks
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.
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Jean Grem, MD
University of Nebraska
11 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2019
First Posted
October 28, 2019
Study Start
February 12, 2021
Actual (reported)Combination Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
IV administration over 90 minutes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 13, 2025
Actual (reported)Study Completion
May 13, 2025
Actual (reported)Last Updated
October 21, 2026
Results First Posted
October 21, 2026
Record last verified: 2025-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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