FOLFIRINOX With Digoxin in Patients With Resectable Pancreatic Cancer

Status Recruiting

Clinical Trial Summary

Purpose: 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 patients with resectable pancreatic cancer.

Clinical Trial Description

Methods: Patients with resectable pancreatic cancer will be treated with oxaliplatin 85 mg/m² IV over 2 hours, irinotecan 150 mg/m² given concurrently with folinic acid 400 mg/m² IV over 90 min, followed by a 46-hour infusion of 5-fluorouracil 2400 mg/m². Slow oral digitalization will be used starting with a daily dose of 0.125 (patients over age 65) or 0.25 mg (patients 65 or younger) PO daily. A steady-state will be achieved after five half-lives, which is about 7 to 10 days in the average subject. The initial blood level will be obtained one week after starting digoxin. Assuming the digoxin level is at steady-state and the renal function is stable, there is a linear relationship between digoxin dose and serum concentration. The target digoxin level is between 0.8 to 1.2 ng/mL. Patients will receive IV chemotherapy at 2 week intervals. Restaging imaging will be performed after 4 doses. If the patient has stable or responsive disease, an additional 4 doses will be given followed by restaging imaging. The patient will then undergo surgical exploration ~ 4 weeks after the last dose of chemotherapy. Clinical Endpoints: Primary Endpoints: clinical toxicity. Other endpoints: status of pathologic margins, response rate, pathologic stage, progression-free survival, and overall survival. Correlative Endpoints: Baseline exome sequencing of circulating cell free tumor DNA. Measurement of quantity of circulating cell free tumor DNA at 4 week intervals while on chemotherapy and prior to surgery; resume at 3 month intervals after surgery. Genomic DNA will be collected at baseline for pharmacogenetic studies of polymorphisms that may be pertinent for the drugs used in the study. Blood will be collected for analysis of possible biomarkers of response to digoxin modulation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04141995
Study type	Interventional
Source	University of Nebraska
Contact	Jessi E Delaney, RN
Phone	402-559-1212
Email	jessdelaney@unmc.edu
Status	Recruiting
Phase	Phase 2
Start date	February 12, 2021
Completion date	February 2025

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT05435053` - Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer	Phase 2
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT03109041` - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source	Phase 1
Recruiting	`NCT06065891` - Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer	N/A
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Recruiting	`NCT05048524` - Peri-operative SLOG for Localized Pancreatic Cancer	Phase 2
Suspended	`NCT05124743` - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting	`NCT05351983` - Patient-derived Organoids Drug Screen in Pancreatic Cancer	N/A
Recruiting	`NCT05679674` - Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer	N/A
Recruiting	`NCT05501379` - Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
Recruiting	`NCT04851106` - Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
Enrolling by invitation	`NCT04466189` - Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
Not yet recruiting	`NCT06036563` - Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
Terminated	`NCT01313416` - Gemcitabine and CT-011 for Resected Pancreatic Cancer	Phase 2
Recruiting	`NCT01411072` - Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer	N/A
Active, not recruiting	`NCT01448668` - Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)	N/A
Completed	`NCT01155882` - Registry Study - Whipple at the Splenic Artery
Recruiting	`NCT04970056` - Pancreatic Cancer Early Detection Consortium
Recruiting	`NCT04140526` - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC	Phase 1/Phase 2
Withdrawn	`NCT03682744` - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)	Phase 1