Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma (PANC-001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04270929|
Recruitment Status : Suspended (Recruitment paused)
First Posted : February 17, 2020
Last Update Posted : March 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: FOLFIRI Drug: FOLFIRINOX Device: TriSalus Infusion System||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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|
|Masking:||None (Open Label)|
|Official Title:||Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma|
|Actual Study Start Date :||December 23, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
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.
Device: TriSalus Infusion System
The TriSalus Infusion System administers therapeutics using PEDD technology.
- 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
- 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).
- To determine local progression free survival [ Time Frame: 3 months ]Assess the time frame of pancreatic tumor stability prior to progression by radiographic imaging
- To determine systemic progression free survival. [ Time Frame: 3 months ]Assess the time frame of metastatic tumor stability prior to progression by radiographic imaging
- 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.
- Radiographic response rates by PET [ Time Frame: 3 months ]Changes in tumor metabolic activity
- Radiographic response rate by perfusion MRI [ Time Frame: 3 months ]Changes in tumor size
- Serologic response rates (CA 19-9) [ Time Frame: 3 months ]Serial measurement of serum CA 19-9 levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270929
|United States, Rhode Island|
|Roger Williams Medical Center|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Rathore||Roger Williams Medical Center|