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

Purpose

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.

nclusion Criteria:

  1. Able to understand and provide written informed consent.
  2. ≥ 18 years of age.
  3. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.
  4. 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.
  5. The primary tumor must be surgically resectable, defined as:

    1. no involvement (abutment or encasement) of the major arteries (celiac, common hepatic and/or superior mesenteric artery);
    2. no involvement or <180° interface between tumor and vessel wall of the portal vein, superior mesenteric vein and/or portal vein/splenic vein confluence.
  6. Adequate hepatic, renal and hematological function.

Exclusion Criteria:

  1. Serum total bilirubin ≥2 x ULN (biliary drainage is allowed for biliary obstruction).
  2. Severe renal impairment (CLcr ≤ 30 ml/min).
  3. Inadequate bone marrow reserves as evidenced by:
  4. ANC ≤ 1,500 cells/μl; or Platelet count ≤ 100,000 cells/μl; or Hemoglobin ≤ 9 g/dL
  5. KPS < 60
  6. Patients who received previous chemotherapy or radiotherapy for pancreatic disease.
  7. Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment.
  8. Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2.
  9. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months.
  10. NYHA Class III or IV congestive heart failure, ventricular

Keywords

pancreatic cancer, tumor cells, FOLNapIRINOX

Principal Investigator

Thomas J George, Jr, M.D.

Department

HEMATOLOGY AND ONCOLOGY

Contact Information

tgeorge@ufl.edu

3522738008


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