drugset / Trial / NCT00320515

Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

NCT00320515

Phase 1/2 Completed 89 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.

Timeline

Start
2004-03
Primary completion
2008-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Pemetrexed Small molecule 600 mg/m2 Intravenous
Subject Pemetrexed Small molecule 700 mg/m2 Intravenous
Subject Pemetrexed Small molecule 800 mg/m2 Intravenous
Subject Pemetrexed Small molecule 900 mg/m2 Intravenous

Indications