Background:Pancreatic cancer is the fourth leading cause of cancer death in the United States. Surgery offers the only chance at cure however, less than 20% are resectable at presentation. A common reason for being classified as unresectable is loco-regional advanced disease. Several phase-I studies of regional administration of chemotherapy have been proven safe. The main advantage of pancreatic cancer targeted arterial infusion of Gemcitabine is achievement of higher local bio-available active drug levels at the tumor bed.The RECLAP trial will offer super selective prolonged administration of Gemcitabine via a subcutaneous port for patients with unresectable locally-advanced pancreatic cancer.Objectives:Primary Objective:To evaluate feasibility and toxicity. To establish the MTDSecondary Objectives:To evaluate response rate using RECIST, PET, Functional MRI and CT perfusion criteriaTo evaluate the conversion rate from unresectable to potentially resectable pancreatic cancer.To determine progression free and overall survival.Eligibility:Locally advanced (unresectable) pancreatic cancer.18 years old or greater with an ECOG 0-2Laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to surgeryDesign:12 patients with unresectable locally-advanced pancreatic cancer will receive super-selective continuous arterial infusion of Gemcitabine over 12 hours.Initial dose will be 300mg/m2 (20% of the normal I.V. dose);treatment will be given every 2 weeks (one cycle = 4 weeks). Every cycle the dose will be increased (300, 600, 1000 and 1200m2) unless grade-2 pancreatic specific toxicity ensues.12 patients will be divided into 3 groups. Group-1 will start on 300mg/m2, group-2 on 600mg/m2 and group-3 on 1000mg/m2, unless previous DLT.Patients will be evaluated every 2 cycles. Upon progression patients will be taken off study but continued to be followed.If no PD patients will continue up to six cycles.
| Ray, Satyajit; Langan, Russell C; Mullinax, John E et al. (2012) Establishment of human ultra-low passage colorectal cancer cell lines using spheroids from fresh surgical specimens suitable for in vitro and in vivo studies. J Cancer 3:196-206 |
| Mullinax, John E; Allins, Alexander; Avital, Itzhak (2011) Laparoscopic appendectomy for Amyand's hernia: a modern approach to a historic diagnosis. J Gastrointest Surg 15:533-5 |
| Avital, Itzhak (2011) Regional chemotherapy for pancreatic cancer. J Surg Oncol 104:453 |
