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

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.

Inclusion Criteria:

• histologically confirmed gastric cancer
• inoperable, recurrent, or metastatic
• performance status 0 to 2
• failed after one or more prior chemotherapy for advanced disease
• informed consent

Exclusion Criteria:

• active infection
• severe co-morbidities
• previously treated with irinotecan or similar drugs