Overview

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