A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer

Inclusion Criteria

• •Pathologically confirmed adenocarcinoma of the pancreas.
• •Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist. Criteria defining unresectable and borderline resectable patients will be based on the NCCN Guidelines (v 1.2014):
• •Unresectable
• •Greater than 180 degrees of SMA encasement
• •Any celiac abutment
• •Unreconstructible SMV/portal occlusion
• •Aortic invasion or encasement
• •Nodal metastases beyond the field of resection Borderline resectable
• •Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen
• •Encasement of the SMV/portal vein but without encasement of the nearby arteries
• •Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting.
• •Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis
• •Tumor abutment to SMA but not to exceed greater than 180 degrees of circumferential vessel wall
• •Age \> 18 years.
• •ECOG performance status of ≤ 1.
• •Adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent) and AST \< 5 times the upper limit of normal.
• •Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial.
• •Patients must be able to provide written informed consent.