ALIMTA AND GEMZAR IN ADVANCED PANCREATIC AND BILIARY TRACT CANCER

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项每两周一次的I/II期剂量升级研究，ALIMTA是一种新的抗叶酸药物，与嘌呤途径中的酶相比，在晚期胰腺和胆道癌症的治疗中具有更高的胸腺苷酸合成酶抑制特异性，与另一种化疗药物GEMZAR联合使用。目前还没有很好的治疗胰腺癌和胆道癌的方法，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。该方案是测试不同剂量的ALIMTA与叶酸补充和B12注射治疗这些肿瘤。耐受性（主要是血液学）是终点之一，肿瘤缩小或反应（触诊和CT或MR放射学）也是终点之一。该方案有两个阶段：在第一阶段，患者将接受900-1500mg/m2的Gemzar和300-1000mg/m2的ALIMTA，剂量加速，直到达到最大耐受剂量。患者还将接受地塞米松（4mg / bid）、叶酸和维生素B12治疗。在该方案的第二部分，患者也将测量Gemzar水平。一旦确定了Gemzar和ALIMTA的剂量，患者将以14天为周期接受一个疗程的Gemzar和ALIMTA。总共将招募30名患者。第一阶段将招募10名患者，第二阶段将招募29名患者。

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.