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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Roger Williams Medical Center
Providence, Rhode Island, United States
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
Time frame: 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).
Time frame: 3 months
To determine local progression free survival
Assess the time frame of pancreatic tumor stability prior to progression by radiographic imaging
Time frame: 3 months
To determine systemic progression free survival.
Assess the time frame of metastatic tumor stability prior to progression by radiographic imaging
Time frame: 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.
Time frame: 3 months
Radiographic response rates by PET
Changes in tumor metabolic activity
Time frame: 3 months
Radiographic response rate by perfusion MRI
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Changes in tumor size
Time frame: 3 months
Serologic response rates (CA 19-9)
Serial measurement of serum CA 19-9 levels
Time frame: 3 months