Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer

Inclusion Criteria

• •Histologically documented pancreatic adenocarcinoma not previously treated with systemic therapy.
• •Complete macroscopic and microscopic (R0) resection for ductal adenocarcinoma of the pancreas with no evidence of malignant ascites, peritoneal metastases or distant metastases. Lack of recurrent and/metastatic disease must be confirmed radiologically with CT chest, abdomen, and pelvis prior to enrolment.
• •Adequate tissue available for IHC testing of hENT1. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute (CCI) is required. Paraffin block sufficient for preparing ≥ 6 unstained slides for central storage and testing if required by oncologist.
• •ECOG performance status of 0 - 2. (Appendix B)
• •Age ≥ 18 years
• •Life expectancy of at least 6 months based on discretion of treating
• •Adequate hematologic function defined by the following laboratory parameters: Hemoglobin \> 100, Platelet count \> 100 and Absolute granulocyte count \> 1.5.
• •Adequate hepatic and renal function defined by the following laboratory parameters: AST and ALT ≤ 2.5 X upper limit of institutional normal, bilirubin ≤ upper limit of institutional normal, and calculated creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault formula, if just below 50 mL/min based on this formula then GFR ≥ 50 mL/min as determined.
• •Patients may have received prior curative radiotherapy for a different malignancy (unless radiation was curative therapy to ≥ 25% of bone marrow stores) and patients must have recovered from the toxic effects of this treatment.
• •Patients must be started on protocol ≤ 10 weeks from the date of curative surgical resection, and patients must have recovered from the toxic effects of surgery.
• •Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.