Study of Cetuximab to Treat Gastric Cancer

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cetuximab

Criteria

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