A Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether cetuximab (Erbitux®) with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective.

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

Details

• Lead Sponsor: Peking University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Capecitabine; Cetuximab; Cisplatin

Criteria

Inclusion Criteria:

• Having signed informed consent

• Age 18 to 75 years old

• Histologically confirmed gastric adenocarcinoma

• Unresectable recurrent or metastatic disease

• Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 12 months

• Measurable disease according to the RECIST criteria

• Karnofsky performance status ≥60

• Life expectancy of ≥2 month

• No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks

• ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)

• Serum albumin level ≥3.0g/dL

• Serum AKP < 2.5 times ULN

• Serum creatinine <1.5mg/dL

• Bilirubin level < 1.5mg/dL

• Serum creatinine <1.5 times ULN

• WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

• Brain metastasis (known or suspected)

• Previous systemic therapy for metastatic gastric cancer

• Inability to take oral medication

• Previous EGFR pathway-targeting therapy

• Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry

• Heart failure, coronary artery disease, myocardial infarction within the last 6 months

• Known allergy to any study treatment

• Pregnancy or lactation period

• Any investigational agent within the past 28 days

• Other previous malignancy within 5 year, except non-melanoma skin cancer

• Previous adjuvant therapy with capecitabine+platinum

• Pre-existing neuropathy>grade 1

• Legal incapacity