Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Adenocarcinoma with Molecular Correlates
The objective of this study is to estimate the R0 resection rate in patients with Resectable Pancreatic Ductal Adenocarcinoma (R-PDAC) as well as those with Resectable Pancreatic Ductal Adenocarcinoma (BR-PDAC) independently in response to neoadjuvant sequential therapy of combination nab-paclitaxel and gemcitabine followed by stereotactic body radiotherapy (SBRT).
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma.
No evidence of distant metastasis representing stage IV metastatic disease.
R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture.
BR-PDAC: defined as localized PDAC with 1 or more of the following features: a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short-segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall.
Age > 18 years old
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must have adequate bone marrow function:
Platelets >100,000 cells/mm3
Hemoglobin > 9.0 g/dL
Absolute Neutrophil Count > 1,500 cells/mm3
Patients must have adequate liver function:
aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 X upper limit of normal
Alkaline phosphatase < 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
Total bilirubin < 1.5 mg/dL
Patients must have adequate renal function: creatinine <1.5 mg/dL is recommended; however, institutional norms are acceptable. Creatinine within institutional limits of normal or creatinine clearance (CrCl) > 50 mL/min calculated using the Cockcroft-Gault equation.
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
Negative serum or urine ?-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential.
Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE 4.03).
Ability to understand and willingness to sign a written informed consent.
Primary disease category: Cancer
Sponsor: University of Colorado / Celgene
Projected enrollment dates: June 2017 to April 2018
Official study title: Perioperative Therapy for Resectable and Borderline Resectable Pancreatic Adenocarcinoma with Molecular Correlates