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

NCT04270929 | Withdrawn Phase 1 FDA Drug FDA Device

• 1 other identifier: 342-30
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Unresectable Pancreatic Cancer; Metastatic Pancreatic Cancer; Oxaliplatin; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• To determine local progression free survival

  3 months

• To determine systemic progression free survival.

  3 months

• To determine overall survival

  3 months

• Radiographic response rates by PET

  3 months

• Radiographic response rate by perfusion MRI

  3 months

Study Arms (1)

Oxaliplatin PEDD-PRVI

EXPERIMENTAL

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; Drug: FOLFIRINOX; Device: TriSalus Infusion System

Interventions

FOLFIRI DRUG

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

Oxaliplatin PEDD-PRVI

FOLFIRINOX DRUG

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

Oxaliplatin PEDD-PRVI

TriSalus Infusion System DEVICE

The TriSalus Infusion System administers therapeutics using PEDD technology.

Oxaliplatin PEDD-PRVI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-
• FOLFIRINOX chemotherapy was completed more than six months ago,
• Patients who are currently candidates for re-challenge with FOLFIRINOX chemotherapy for their recurrent cancer, and
• 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-
• Patients have received no more than six cycles of FOLFIRINOX chemotherapy,
• Patients have at least stable disease on imaging, and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roger Williams Medical Center: lead
• TriSalus Life Sciences, Inc.: collaborator

Study Sites (1)

Roger Williams Medical Center

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

IFL protocol; folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Rathore

  Roger Williams Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Hematology/Oncology

Model Details: This is an open label, single institution, single-arm, dose-escalation phase 1 study, designed to assess the feasibility, safety, and efficacy of oxaliplatin PEDD-PRVI with systemic FOLFIRI followed by FOLFIRINOX therapy for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 17, 2020
• Study Start: December 23, 2019
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)