Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer

Study Phase: Pilot study to assess nab-paclitaxel in combination with gemcitabine effects on pancreatic cancer stroma and tumor metabolism. Study Objective(s): A) Primary end-points: 1. Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density. 2. Evaluate the effect of nab-paclitaxel on tumor vessels formation. 3. Evaluate the effect of nab-paclitaxel on tumor metabolism. B) Secondary end-point: 1\. Evaluate combination activity in relation with changes in tumor stroma and tumor metabolic activity. The following studies will be performed prior and after treatment administration: * 18FDG-PET/CT scan; * Ultrasound Elastography; * IHC: 1. SPARC; 2. Microvessel Density (CD-31, VEGF-A); 3. Stroma density (SMA and Collagen I). Study population and Number of subject: A total of 15 pancreatic cancer patients with resectable/resectable borderline disease are expected to be enrolled. Study design and schedule: This is a pilot study to evaluate the effect of nab-paclitaxel on tumor stroma in pancreatic cancer patients. The study will be conducted in two parts: Part A: Patients diagnosed with resectable/resectable pancreatic cancer will be screened for SPARC expression. Fifteen, SPARC positive patients, will be enrolled in the study and treated with nab-paclitaxel in combination with gemcitabine. Patients will be treated as follow: * nab-paclitaxel will be administered at 125 mg/m2 as intravenous (i.v.) infusion over 30 minutes; * followed by gemcitabine 1000 mg/m2 i.v. infusion over 30 minutes; Treatment will be delivered weekly, for 3 weeks (on day 1, 8, and 15 over 28 days cycle) followed by a week of rest, for two cycles of treatment. Part B: At the end of treatment tumors will be surgically resected according to standard surgical procedure for the treatment of pancreatic cancer.