drugset / Trial / NCT00509964

Second-Line Irinotecan vs. ILF for AGC

NCT00509964 ↗

Phase 2 Unknown 50 enrolled Gachon University Gil Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients with recurrent or metastatic gastric cancer can benefit from palliative chemotherapy. However, over half of patients with metastatic gastric cancer who received chemotherapy failed to achieve response and even in these responders, the duration of responses was as short as a few months. Patients with metastatic gastric cancer who fail to respond or have relapse after first line chemotherapy have a grim prognosis and a standard salvage treatment is not available. We designed this phase II trial to determine the efficacy and safety of irinotecan monotherapy or combination (ILF) as second-line therapy for advanced gastric cancer.

Timeline

Start
2007-05
Primary completion
—
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Irinotecan Small molecule 150 mg/m2 Intravenous
Comparator Leucovorin Small molecule — —
Comparator fluorouracil Small molecule — —

Indications