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Terminated
NCT04141995
FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer
Conditions: Pancreas Cancer, Adenocarcinoma of the Pancreas
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 11
Sponsor: University of Nebraska
Location: University of Nebraska Medical Center Omaha Nebraska
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT04141995). StuddyBuddy aggregates publicly available trial information.