A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer

This study has been completed.

Sponsored by:	West Japan Thoracic Oncology Group
Information provided by:	West Japan Thoracic Oncology Group
ClinicalTrials.gov Identifier:	NCT00144066

Purpose

A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.

Condition	Intervention	Phase
Lung Cancer	Drug: platinum-based chemotherapy alone (up to six cycles) Drug: platinum-based chemotherapy followed by maintenance therapy with gefitinib	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer

Further study details as provided by West Japan Thoracic Oncology Group:

Primary Outcome Measures:

Over all survival

Secondary Outcome Measures:

Time to disease progression

Estimated Enrollment:	600
Study Start Date:	January 2003

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed NSCLC Stage IIIB/IV No prior treatment Measurable disease ECOG PS 0-1 Adequate organ function Age 20-74 Written informed consent

Exclusion Criteria:

Pregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144066

Sponsors and Collaborators

West Japan Thoracic Oncology Group

Investigators

Principal Investigator:

Toyoaki Hida, MD, PhD

West Japan Thoracic Onoclogy Group

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	WJTOG0203
Study First Received:	August 31, 2005
Last Updated:	September 1, 2005
ClinicalTrials.gov Identifier:	NCT00144066
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009