CLINICAL TRIAL: ALIMTA AND GEMZAR IN ADVANCED PANCREATIC AND BILIARY TRACT CANCE

临床试验：ALIMTA 和 GEMZAR 治疗晚期胰腺癌和胆道癌

• 批准号: 7718420
• 负责人: HOWARD S HOCHSTER
• 金额: $ 0.09万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718420
• 关键词: Acceleration; Alimta; Biliary Tract Cancer; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dexamethasone; Dose; End Point; Enrollment; Enzymes; Folate; Folic Acid; Funding; Grant; Injection of therapeutic agent; Institution; Maximum Tolerated Dose; Measurement; Palpation; Pancreas; Pathway interactions; Patients; Phase; Protocols documentation; Purines; Research; Research Personnel; Resources; Source; Specificity; Supplementation; Testing; Thymidylate Synthase; United States National Institutes of Health; biliary tract; chemotherapy; day; gemzar; purine; response; tumor

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项双周ALIMTA（一种新型抗叶酸剂，在晚期胰腺癌和胆道癌治疗中对胸苷酸合成酶的抑制特异性高于嘌呤途径中的酶）与另一种化疗药物GEMZAR联合给药的I/II期剂量递增研究。 胰腺癌和胆道癌没有很好的治疗方法，尽管最近的研究表明吉西他滨可能是有用的，ALIMTA也可能有一定的疗效。 本方案旨在测试不同剂量的ALIMTA与叶酸补充剂和B12注射剂对这些肿瘤的治疗作用。 耐受性（主要是血液学）是终点之一，肿瘤缩小或缓解（触诊和CT或MR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的健择加300- 1000 mg/m2的ALIMTA，剂量加速直至达到最大耐受剂量。 患者还将接受地塞米松（4 mg po bid）、叶酸和维生素B12。 在本方案的第二部分，患者还将测量健择水平。 一旦确定健择和ALIMTA的剂量，患者将接受健择和ALIMTA的疗程，每14天为一个周期。 总共将入组30例患者。 在第一阶段，将招募10名患者，在第二阶段，将招募29名患者。