First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00322452

Purpose

The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Gefitinib Drug: Carboplatin Drug: Paclitaxel	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare gefitinib with carboplatin/paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival.

Secondary Outcome Measures:

To compare Iressa v carboplatin/paclitaxel in terms of overall survival
To compare Iressa carboplatin/paclitaxel in terms of objective tumour response rate
To compare the safety and tolerability profile of Iressa v carboplatin/paclitaxel

Enrollment:	1220
Study Start Date:	March 2006
Estimated Study Completion Date:	July 2009

Arms	Assigned Interventions
1: Experimental gefitinib	Drug: Gefitinib oral tablet
2: Active Comparator Carboplatin/Paclitaxel	Drug: Carboplatin Drug: Paclitaxel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology.
Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)

Exclusion Criteria:

Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322452

Show 56 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Nick Botwood, MD

AstraZeneca

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D791AC00007, Iressa Pan Asian Study (IPASS)
Study First Received:	May 5, 2006
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00322452
Health Authority:	Hong Kong: Department of Health

Keywords provided by AstraZeneca:

NSCLC
Gefitinib

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents

Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009