Pancreatic perfusion for locally unresectable pancreatic cancer

局部不可切除胰腺癌的胰腺灌注

• 批准号: 8349485
• 负责人: Itzhak Avital
• 金额: $ 11.51万
• 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/8349485
• 关键词: 18 year old; 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; Laboratories; 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; design; 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 MTD Secondary Objectives: To evaluate response rate using RECIST, PET, Functional MRI and CT perfusion criteria To 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 0-2 Laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to surgery Design: 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。 手术提供了治愈的唯一机会，然而，不到20%的患者在就诊时可切除。 被归类为不可切除的常见原因是局部区域晚期疾病。 几项区域化疗的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势是在肿瘤床实现更高的局部生物可利用活性药物水平。RECLAP试验将为不可切除的局部晚期胰腺癌患者提供超选择性吉西他滨皮下给药。目的：主要目的：评估可行性和毒性。 确立MTD次要目的：使用RECIST、PET、功能性MRI和CT灌注标准评价缓解率，评价胰腺癌从不可切除转为可能可切除的转化率。确定无进展生存期和总生存期。入选标准：局部晚期（不可切除）胰腺癌。18岁或以上，ECOG 0 - 2实验室和体格检查参数在手术前标准实践指南的可接受范围内。设计：12名不可切除的局部晚期胰腺癌患者将接受超选择性连续动脉输注吉西他滨超过12小时。初始剂量为300 mg/m2（正常静脉注射剂量的20%）;治疗将每2周一次（一个周期= 4周）。每个周期的剂量将增加（300、600、1000和1200 m2），除非出现2级胰腺特异性毒性。将12例患者分为3组。第1组将从300 mg/m2开始，第2组从600 mg/m2开始，第3组从1000 mg/m2开始，除非既往DLT。每2个周期对患者进行一次评价。进展后，患者将退出研究，但继续接受随访。如果没有PD，患者将继续最多6个周期。