Phase II Iressa & Carbo/Gem in NSCLC - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00264498

Purpose

The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Gefitinib Drug: Gemcitabine Drug: Carboplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Gemcitabine hydrochloride Gemcitabine ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Progression Free Survival (PFS [ Time Frame: assessed from the date of randomization to the date of the first documented evidence of PD, or to the last date the patient was known to be alive ] [ Designated as safety issue: No ]

Estimated Enrollment:	122
Study Start Date:	October 2004
Study Completion Date:	June 2008

Arms	Assigned Interventions
1: Active Comparator Gemcitabine + Carboplatin	Drug: Gemcitabine intravenous injection Drug: Carboplatin intravenous injection
2: Experimental Gefitinib	Drug: Gefitinib oral tablet

Eligibility

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

Criteria

Inclusion Criteria:

Advanced Non Small cell Lung Cell Lung cancer
Never received chemotherapy
Up and about 50% of waking hours

Exclusion Criteria:

Spread of lung cancer to the brain
Low level of white blood cells
Radiotherapy within 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264498

Locations

Canada, Quebec
Research Site
Montreal, Quebec, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Canada Oncology Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839IL/0551
Study First Received:	December 12, 2005
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00264498
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Non-Small-Cell Lung Cancer
NSCLC
Lung Cancer

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009