ALIMTA AND GEMZAR IN ADVANCED PANCREATIC AND BILIARY TRACT CANCER

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项双周ALIMTA的I/II期剂量递增研究，ALIMTA是一种新的抗叶酸，在治疗晚期胰腺癌和胆道癌中，与另一种化疗药物Gemzar联合使用，在抑制胸苷合成酶方面比嘌呤途径中的酶具有更强的特异性。目前还没有治疗胰腺癌和胆道癌的好方法，尽管最近对Gemzar的研究表明它可能是有用的，ALIMTA也可能有一些疗效。该方案旨在测试不同剂量的ALIMTA与叶酸补充和B12注射治疗这些肿瘤的效果。耐受性(主要是血液学)是终点之一，肿瘤缩小或反应(CT或MR触诊和放射学检查)也是终点之一。该方案分为两个阶段：第一阶段，患者将接受900-1500 mg/m2的Gemzar和300-1000 mg/m2的ALIMTA，并进行剂量加速，直到达到最大耐受量。患者还将接受地塞米松(4毫克，口服，2次)、叶酸和维生素B12。在该方案的第二部分，患者还将进行Gemzar水平的测量。一旦确定了Gemzar和ALIMTA的剂量，患者将接受14天周期的Gemzar和ALIMTA疗程。总共将有30名患者入选。第一阶段10名患者入选，第二阶段29名患者入选。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase I/II dose escalating study of bi-weekly ALIMTA, a new anti-folate with greater specificity for inhibition of thymidylate synthase than enzymes in the purine pathway in the therapy of advanced pancreatic and biliary tract cancer, in combination with GEMZAR, another chemotherapy agent. There are no good therapies for pancreatic and biliary tract cancer, although recent studies with GEMZAR have suggested that it may be useful, and ALIMTA may also have some efficacy. This protocol is to test varying doses of ALIMTA with folic acid supplementation and B12 injections for the therapy of these tumors. Tolerability (primarily hematologic) is one of the endpoints, as is tumor shrinkage or response (palpation and radiologic with either CT or MR). There are two phases of this protocol: In the first, patients will receive 900-1500mg/m2 of Gemzar plus 300-1000mg/m2 of ALIMTA with dose acceleration until maximum tolerated dose is achieved. Patients will also receive dexamethasone (4mg po bid), folic acid and Vit B12. In the second part of this protocol patients will also have measurements of Gemzar levels made. Once the doses of Gemzar and ALIMTA are determined, patients will receive a course of Gemzar and ALIMTA in 14-day cycles. 30 patients will be enrolled overall. In the first phase, 10 patients will be enrolled, and in the second, 29 patients.