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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

December 12, 2005
June 11, 2009
October 2004
Not Provided
Progression Free Survival (PFS) [ Time Frame: Date of randomization to earliest date of objective disease progression ] [ Designated as safety issue: No ]
Progression Free Survival (PFS). PFS will be 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
Complete list of historical versions of study NCT00264498 on ClinicalTrials.gov Archive Site
Not Provided
(Other measures that will be used to evaluation the intervention and that are listed in the the protocol. The description should include the time at which the measures will be taken).
Not Provided
Not Provided
 
Phase II Iressa & Carbo/Gem in NSCLC
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: Gefitinib
    oral tablet
    Other Names:
    • IRESSA
    • ZD1839
  • Drug: Gemcitabine
    intravenous injection
    Other Name: Gemzar
  • Drug: Carboplatin
    intravenous injection
    Other Name: CBDCA
  • Active Comparator: 1
    Gemcitabine + Carboplatin
    Interventions:
    • Drug: Gemcitabine
    • Drug: Carboplatin
  • Experimental: 2
    Gefitinib
    Intervention: Drug: Gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
June 2008
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00264498
1839IL/0551
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Canada Oncology Medical Director, MD AstraZeneca
AstraZeneca
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP