Pancreatic perfusion for locally unresectable pancreatic cancer

局部不可切除胰腺癌的胰腺灌注

• 批准号: 8553118
• 负责人: Itzhak Avital
• 金额: $ 7.33万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8553118
• 关键词: Achievement; Beds; Cancer Etiology; Cessation of life; Dose; Eastern Cooperative Oncology Group; Eligibility Determination; Functional Magnetic Resonance Imaging; Hour; Implantable venous access port; Infusion procedures; Malignant neoplasm of pancreas; Operative Surgical Procedures; Pancreas; Patients; Perfusion; Pharmaceutical Preparations; Physical Examination; Positron-Emission Tomography; Practice Guidelines; Regional Chemotherapy; Resectable; Toxic effect; United States; Unresectable; advanced disease; chemotherapy; gemcitabine; phase 1 study; response; tumor

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.

背景：胰腺癌是美国癌症死亡的第四大原因。手术提供了唯一的治愈机会，然而，不到20%的患者在发病时可以切除。被归类为不可切除的一个常见原因是局部-区域性晚期疾病。一些区域给药化疗的i期研究已被证明是安全的。胰腺癌靶向动脉输注吉西他滨的主要优点是在肿瘤床上获得更高的局部生物利用活性药物水平。RECLAP试验将为无法切除的局部晚期胰腺癌患者提供超选择性延长吉西他滨皮下给药。目的：主要目的：评价其可行性及毒性。次要目的：应用RECIST、PET、功能性MRI和CT灌注标准评价反应率评价不可切除胰腺癌向潜在可切除胰腺癌的转归率。确定无进展期和总生存期。资格：局部晚期（不可切除）胰腺癌。18岁或以上，ECOG 0-2，术前实验室和体检参数在标准实践指南可接受范围内设计：12例不可切除的局部晚期胰腺癌患者接受超选择性连续动脉输注吉西他滨12小时。初始剂量300mg/m2（正常静脉注射剂量的20%）；每2周治疗一次（一个周期= 4周）。每个周期剂量将增加（300,600,1000和1200m2），除非随后发生2级胰腺特异性毒性。12例患者分为3组。第一组将开始300mg/m2，第二组为600mg/m2，第三组为1000mg/m2，除非之前的DLT。每2个周期对患者进行评估。一旦进展，患者将停止研究，但继续随访。如果没有PD患者将持续6个周期。