drugset / Trial / NCT00195572

Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

NCT00195572

Phase 3 Completed 200 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).

Timeline

Start
2002-05
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Levoleucovorin Unknown
Subject S-1 Small molecule

Indications