Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

Inclusion Criteria14

• Be 18 years of age or older.
• Be able to understand and provide written informed consent or have a legally authorized representative (LAR).
• Have an Eastern Cooperative Group (ECOG) performance status < 2 (please see the appendix).
• Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study.
• Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings.
• Have adequate organ and bone marrow function, as defined by:
• total leukocytes >3 x10\^3/μL.
• absolute neutrophil count (ANC) >1.5x 10\^3/μL.
• hemoglobin >9 g/dL.
• platelets >100 x 10\^3/μL.
• creatinine clearance >60 mL/min or creatinine <1.5 mg/dL; bilirubin < 2 mg/dL.
• aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) <3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial principal investigators.
• Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 > 35 U/mL, when total bilirubin <2 mg/dL.
• Female patients must be postmenopausal (absence of menses for > 1 year), surgically sterile, or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study, during study treatment and during the first four months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for four months after the last dose of any study drug.