A Phase II Study of Cetuximab(Erbitux) With Cisplatin and Capecitabine(Xeloda)as 1st Line Treatment in the Advanced Gastric Cancer - Full Text View

Sponsors and Collaborators:	Peking University Merck
Information provided by:	Peking University
ClinicalTrials.gov Identifier:	NCT00477711

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer	Drug: cetuximab, cisplatin, capecitabine	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin Capecitabine Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Peking University:

Primary Outcome Measures:

Tumor response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression Disease control rate Overall survival K-ras, b-raf, p53 gene mutation and EGFR gene copy number vs. tumor response safety [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	41
Study Start Date:	March 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Product 1: Cetuximab(Erbitux®) Dosing schedule: 400mg/m2 initial dose and then 250mg/m2 ,weekly dose Mode of administration: intravenously Product 2: capecitabine Dosing schedule: 1000mg/m2 bid, days 1-14, every 3 weeks Mode of administration: orally Product 3: cisplatin Dosing schedule: 80mg/m2, day 1 of every 3 weeks Mode of administration: intravenously

Detailed Description:

Gastric cancer remains one of the major causes of cancer deaths around the world, especially in Asia. Previous study of ML17032 has proved that XP(capecitabine plus cisplatin)is effective in advanced gastric cancer, with the overall response rate of 41%, the median PFS of 5.6 month. Recently, the EGFR monoclonal antibody of cetuximab has shown to be successful in treating advanced colorectal cancer with or without chemotherapy. Since EGFR also express in gastric cancer, A single arm, open, multicenter phase II study of cetuximab in combination with cisplatin and capecitabine as first line treatment in patient with advanced gastric cancer.If applicable, the value of mutations in k-ras, b-raf, P53, and EGFR copy number to predict the clinical response to cetuximab in advanced gastric cancer patients will also be accessed.Tumor tissue from study patients will be checked for k-ras, b-raf, and P53 mutation by sequencing and for EGFR copy number by chromogenic in situ hybridization. DNA will be extracted from paraffin-embedded samples.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477711

Locations

China
Peking University,School of Oncology, Gastrointestinal Department
Beijing, China, 100036

Sponsors and Collaborators

Peking University

Merck

Investigators

Principal Investigator:

Lin Shen, MD

Peking University, School of oncology, Gastrointestinal Department

More Information

Responsible Party:	Peking University, School of Oncology, Department of GI oncology ( Xiaotian Zhang )
Study ID Numbers:	EMR 62202-769
Study First Received:	May 22, 2007
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00477711
Health Authority:	China: State Food and Drug Administration

Keywords provided by Peking University:

Cetuximab
cisplatin
capecitabine
first line treatment

Study placed in the following topic categories:

Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin

Gastrointestinal Diseases
Stomach Neoplasms
Cetuximab
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009