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

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.