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

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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.