Study of Cetuximab to Treat Gastric Cancer

Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy

The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.

Inclusion Criteria:

• Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
• ECOG performance scale ≤ 1
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
• Adequate hepatic, renal, heart, and hematologic functions (platelets>80 × 109/L, neutrophil>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

• Pregnant or lactating women
• Concurrent cancer
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Neuropathy, brain, or leptomeningeal involvement
• Uncontrolled significant comorbid conditions and previous radiotherapy