NCT00509964

Second-Line Irinotecan vs. ILF for AGC

A Randomized Phase II Trial of Irinotecan Monotherapy Versus Irinotecan, Leucovorin and 5-FU (ILF) Combination Chemotherapy in Patients With Advanced Gastric Cancer Failing Prior Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomach Neoplasm
• Metastatic
• Second-Line

Interventions

Type	Name	Description
DRUG	irinotecan	Patients will receive irinotecan 150 mg/m2 intravenously on day 1 every 2 weeks.
DRUG	ILF	Patients will receive irinotecan 150 mg/m2 intravenously, in combination with leucovorin and 5-fluorouracil, on day 1 every 2 weeks.

Timeline

• Start date: 2007-05-01
• Completion: 2007-07-01
• First posted: 2007-08-01
• Last updated: 2007-08-01

Locations

1 site across 1 country: South Korea