Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma

Study Overview

This is an open label, single institution, dose-escalation phase 1 study designed to assess the feasibility, safety, and efficacy of oxaliplatin administered via Pancreatic Retrograde Venous Infusion (PRVI) using Pressure Enabled Drug Delivery (PEDD) technology. Oxaliplatin PEDD-PRVI is administered with systemic FOLFIRI followed by FOLFIRINOX therapy for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma.

The treatment period consists of 6 cycles. Cycles 1 and 2 involve the regional administration of oxaliplatin via PEDD-PRVI with systemic FOLFIRI. During cycles 1 and 2, patients are evaluated on days 1, 2, 4, and 8. Cycles 3 through 6 include the systemic administration of standard of care FOLFIRINOX. During cycles 3 through 6, patients are evaluated on days 1 and 8.

Pancreatic Adenocarcinoma

DRUG: FOLFIRI
DRUG: FOLFIRINOX
DEVICE: TriSalus Infusion System

342-30

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-01-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-05-27
First Submitted that Met QC Criteria 2020-02-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-06-01
First Posted (ACTUAL) 2020-02-17	Results First Posted N/A	Last Verified 2021-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Oxaliplatin PEDD-PRVI Two infusions of oxaliplatin (dose escalation: 20-40 mg) over the course of 4 weeks by Pancreatic Retrograde Venous Infusion (PRVI) utilizing Pressure Enabled Drug Delivery (PEDD) technology.	DRUG: FOLFIRI During Cycles 1 and 2, standard of care systemic FOLFIRI will be delivered on Days 2-4 following oxaliplatin PEDD-PRVI. DRUG: FOLFIRINOX During Cycles 3-6, standard of care systemic FOLFIRINOX will be administered on Days 1-3. DEVICE: TriSalus Infusion System The TriSalus Infusion System administers therapeutics using PEDD technology.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Oxaliplatin PEDD-PRVI

Two infusions of oxaliplatin (dose escalation: 20-40 mg) over the course of 4 weeks by Pancreatic Retrograde Venous Infusion (PRVI) utilizing Pressure Enabled Drug Delivery (PEDD) technology.

DRUG: FOLFIRI

During Cycles 1 and 2, standard of care systemic FOLFIRI will be delivered on Days 2-4 following oxaliplatin PEDD-PRVI.

DRUG: FOLFIRINOX

During Cycles 3-6, standard of care systemic FOLFIRINOX will be administered on Days 1-3.

DEVICE: TriSalus Infusion System

The TriSalus Infusion System administers therapeutics using PEDD technology.

Primary Outcome Measures	Measure Description	Time Frame
Completion Rate of oxaliplatin PEDD-PRVI	To determine the completion rate of oxaliplatin delivery by PEDD-PRVI as measured by the percentage of successful placements of the TriSalus Infusion System and delivery of the assigned dose of oxaliplatin regionally into the pancreas via RVI per each patient, at each dose-level, and across all enrolled patients in the study. Successful delivery of oxaliplatin by PEDD-PRVI will be confirmed using real-time fluoroscopic guidance. The success rate of completion of PEDD-RVI per patient and acroos all-patients will be calculated	3 months
Safety of oxaliplatin PEDD-PRVI: maximum tolerable dose (MTD)	To determine the safety of oxaliplatin PEDD-PRVI by identifying the maximum tolerable dose (MTD).	3 months

Secondary Outcome Measures	Measure Description	Time Frame
To determine local progression free survival	Assess the time frame of pancreatic tumor stability prior to progression by radiographic imaging	3 months
To determine systemic progression free survival.	Assess the time frame of metastatic tumor stability prior to progression by radiographic imaging	3 months
To determine overall survival	As a measure of activity, overall survival will be assessed. The events for the assessment of overall survival are death events.	3 months
Radiographic response rates by PET	Changes in tumor metabolic activity	3 months
Radiographic response rate by perfusion MRI	Changes in tumor size	3 months
Serologic response rates (CA 19-9)	Serial measurement of serum CA 19-9 levels	3 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patient with histologically confirmed diagnosis of adenocarcinoma of the pancreas. Patient must have either histologic confirmation of the primary tumor or metastasis.
Patients must have locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
Patient must be between 18 - 80 years of age.
Patient able to understand and sign informed consent.
Patient may be chemotherapy naïve or may have failed one line of conventional therapy
Prior FOLFIRINOX therapy:

Patients who have previously received FOLFIRINOX chemotherapy for locally advanced unresectable pancreatic cancer are eligible for enrollment upon this study if they meet the following criteria-

Patients with metastatic cancer who are currently receiving FOLFIRINOX chemotherapy are eligible for enrollment upon this study if they meet the following criteria-

Patient with a life expectancy of greater than six months.
Patient with performance status of 0 to 1 (ECOG).
All patients must have adequate organ function as defined by:

ANC greater than or equal to 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ to 8 g/dL; patient may be transfused to achieve Hgb ≥ 8 g/dL to satisfy enrollment criteria, or as otherwise indicated by symptoms for Hgb > 8 g/dL.
Creatinine ≤ 1.5mg/dl or creatinine clearance ≤ 60cc/min.
Direct bilirubin <1.5X ULN, alkaline phosphatase <5X ULN, and ALT/AST <5X ULN (ULN = upper limit of normal).
No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, including uncontrolled atrial fibrillation/atrial flutter, evidence of prior myocardial infarction by history or EKG.
No serious, symptomatic obstructive or emphysematous lung disease, or asthma requiring intravenous medications within the past 12 months; no serious lung disease associated with dyspnea at normal activity levels (grade III) or at rest (grade IV), due to any cause (including cancer metastases and pleural effusions).
Acceptable vascular anatomy as determined by CT, MR, or conventional venography.

Female patients of childbearing age will be tested for pregnancy. Pregnant and breastfeeding patients will be excluded from the study. Males who are actively seeking to have children will be made aware of the unknown risks of this study protocol on human sperm and the need to practice birth control.
Patients with serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic, or allergic disease based on history, physical exam and laboratory tests will be excluded.
Patients with uncontrolled diabetes mellitus or a history of pancreatitis.
Patients with cholelithiasis and a history of choledocholithiasis.
Patients with concurrent malignancies, except for cutaneous carcinomas.
Patients with unsuitable vascular anatomy.
Portal vein occlusion/thrombosis, history of portal hypertension, cirrhosis, hepatitis, or with radiographic evidence of cirrhosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

TriSalus Life Sciences, Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Rathore, Roger Williams Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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