A Phase II, Open-label Evaluating the Safety and Activity of naI-IRI in Combination with 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma
To establish the safety and feasibility of ONIVYDE® in combination with 5-fluorouracil, leucovorin, and oxaliplatin (FOLNapIRINOX) in the neoadjuvant setting of resectable pancreatic cancer.
- Able to understand and provide written informed consent.
- ≥ 18 years of age.
- Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.
- Patients must have measurable disease in the pancreas, with no evidence of metastatic disease on imaging of the chest, abdomen and pelvis (contrast-enhanced CT or MRI abdomen with contrast instead of abdominal CT); PET scans alone will not be adequate alternatives.
The primary tumor must be surgically resectable, defined as:
- no involvement (abutment or encasement) of the major arteries (celiac, common hepatic and/or superior mesenteric artery);
- no involvement or <180° interface between tumor and vessel wall of the portal vein, superior mesenteric vein and/or portal vein/splenic vein confluence.
- Adequate hepatic, renal and hematological function.
- Serum total bilirubin ≥2 x ULN (biliary drainage is allowed for biliary obstruction).
- Severe renal impairment (CLcr ≤ 30 ml/min).
- Inadequate bone marrow reserves as evidenced by:
- ANC ≤ 1,500 cells/μl; or Platelet count ≤ 100,000 cells/μl; or Hemoglobin ≤ 9 g/dL
- KPS < 60
- Patients who received previous chemotherapy or radiotherapy for pancreatic disease.
- Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment.
- Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2.
- Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months.
- NYHA Class III or IV congestive heart failure, ventricular
Keywordspancreatic cancer, tumor cells, FOLNapIRINOX
Principal InvestigatorThomas J George, Jr, M.D.
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