Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)
Trial Parameters
Brief Summary
The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.
Eligibility Criteria
Inclusion Criteria: 1. Cytologic or histologic proof of adenocarcinoma of the pancreas. 2. Nonmetastatic pancreatic cancer. Metastatic disease includes spread to distant (non-regional) lymph nodes, organs, peritoneum and ascites. 3. Unequivocal radiographic findings contraindicating resection including, but not limited to, solid tumor contact with any of the following: 1) the SMA \>180º; 2) the celiac axis \>180º; 3) the first jejunal superior mesenteric artery (SMA) branch; 4) unreconstructible superior mesenteric vein (SMV)/portal vein due to tumor involvement or occclusion; 5) the most proximal draining jejunal branch into the SMV. 4. ECOG Performance Status 0 or 1. 5. Absolute neutrophil count ≥1,000/mm3 6. Platelet count ≥100,000/mm3 7. Creatinine ≤1.5 × upper limit of normal 8. Calculated creatinine clearance \>45 mL/min 9. Total bilirubin ≤2 mg/dL Exclusion Criteria: 1. Patients with resectable or borderline resectable pancreatic cancer are ineligible. 2. No prior definitive res