Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• Gastric cancer diagnosed histologically or cytologically

• Normal organ function of bone marrow, heart, liver and kidney

• Age of 20-77

Other inclusion applies

Exclusion Criteria:

• Serious infection, heart disease, complication or organ disorder

• Ongoing administration of flucytosine

• Pregnant or breastfeeding women

Other exclusion applies