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

NCT ID: NCT04270929

Last Updated: 2021-06-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-23
• Study Completion Date: 2021-05-04

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FOLFIRI

Intervention Type: DRUG

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

FOLFIRINOX

Intervention Type: DRUG

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

TriSalus Infusion System

Intervention Type: DEVICE

The TriSalus Infusion System administers therapeutics using PEDD technology.

Interventions

FOLFIRI

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

Intervention Type: DRUG

FOLFIRINOX

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

Intervention Type: DRUG

TriSalus Infusion System

The TriSalus Infusion System administers therapeutics using PEDD technology.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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-

1. FOLFIRINOX chemotherapy was completed more than six months ago,

2. Patients who are currently candidates for re-challenge with FOLFIRINOX chemotherapy for their recurrent cancer, and

3. Patients have no persistent non-hematologic toxicity greater than grade 1 (due to prior FOLFIRINOX therapy)

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

1. Patients have received no more than six cycles of FOLFIRINOX chemotherapy,

2. Patients have at least stable disease on imaging, and

3. Patients have no persistent non-hematologic toxicity greater than grade 1 (due to ongoing FOLFIRINOX therapy)

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TriSalus Life Sciences, Inc.

INDUSTRY

Sponsor Role: collaborator

Roger Williams Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ritesh Rathore, MD

Director, Division of Hematology/Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rathore

Role: PRINCIPAL_INVESTIGATOR

Roger Williams Medical Center

Locations

Roger Williams Medical Center

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

342-30

Identifier Type: -

Identifier Source: org_study_id