drugset / Trial / NCT00144378

Irinotecan Versus Only Best Supportive Care for Gastric Cancer

NCT00144378 ↗

Phase 3 Completed 44 enrolled Charite University, Berlin, Germany
RandomizedSingle-groupSingle-blind

Summary

The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary. Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.

Timeline

Start
2002-10
Primary completion
—
Completion
—

Outcome

Met primary endpoint

paper The hazard ratio for death was reduced to 0.48 (95%CI 0.25-0.92) in the irinotecan-arm (p=0.012). PMID 21742485 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 350 mg/m2 —