drugset / Trial / NCT00509964
Second-Line Irinotecan vs. ILF for AGC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |