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Phase II Iressa & Carbo/Gem in NSCLC

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00264498
First received: December 12, 2005
Last updated: June 11, 2009
Last verified: June 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Date of randomization to earliest date of objective disease progression ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: October 2004
Study Completion Date: June 2008
Arms Assigned Interventions
Active Comparator: 1
Gemcitabine + Carboplatin
 Drug: Gemcitabine
intravenous injection
Other Name: Gemzar
Drug: Carboplatin
intravenous injection
Other Name: CBDCA
Experimental: 2
Gefitinib
 Drug: Gefitinib
oral tablet
Other Names:
  • IRESSA
  • ZD1839

  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

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.

  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

No publications provided

ClinicalTrials.gov Identifier: NCT00264498     History of Changes
Other Study ID Numbers: 1839IL/0551
Study First Received: December 12, 2005
Results First Received: June 11, 2009
Last Updated: June 11, 2009
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
Non-Small-Cell Lung Cancer
NSCLC
Lung Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Gefitinib
 Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013