Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma (PANC-001)

May 27, 2021 updated by: Ritesh Rathore, MD, Roger Williams Medical Center
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.

Study Overview

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
During Cycles 1 and 2, standard of care systemic FOLFIRI will be delivered on Days 2-4 following oxaliplatin PEDD-PRVI.
During Cycles 3-6, standard of care systemic FOLFIRINOX will be administered on Days 1-3.
The TriSalus Infusion System administers therapeutics using PEDD technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion Rate of oxaliplatin PEDD-PRVI
Time Frame: 3 months
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)
Time Frame: 3 months
To determine the safety of oxaliplatin PEDD-PRVI by identifying the maximum tolerable dose (MTD).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine local progression free survival
Time Frame: 3 months
Assess the time frame of pancreatic tumor stability prior to progression by radiographic imaging
3 months
To determine systemic progression free survival.
Time Frame: 3 months
Assess the time frame of metastatic tumor stability prior to progression by radiographic imaging
3 months
To determine overall survival
Time Frame: 3 months
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
Time Frame: 3 months
Changes in tumor metabolic activity
3 months
Radiographic response rate by perfusion MRI
Time Frame: 3 months
Changes in tumor size
3 months
Serologic response rates (CA 19-9)
Time Frame: 3 months
Serial measurement of serum CA 19-9 levels
3 months

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Rathore, Roger Williams Medical Center

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 Major Dates

Study Start (Actual)

December 23, 2019

Primary Completion (Actual)

May 4, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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