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Iressa Versus Docetaxel (Taxotere)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00076388
Recruitment Status : Completed
First Posted : January 23, 2004
Last Update Posted : May 13, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 21, 2004
First Posted Date  ICMJE January 23, 2004
Last Update Posted Date May 13, 2011
Study Start Date  ICMJE February 2004
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
To compare overall survival between ZD1839 and docetaxel
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00076388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2005)
  • To compare time to progression (TTP) between ZD1839 and docetaxel
  • To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
  • To compare the overall objective tumor response rate between ZD1839 and docetaxel
  • To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
  • To compare safety and tolerability of ZD1839 and docetaxel
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iressa Versus Docetaxel (Taxotere)
Official Title  ICMJE A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy
Brief Summary The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small-Cell Lung Carcinoma
Intervention  ICMJE
  • Drug: Gefitinib
  • Drug: Docetaxel
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 28, 2005)
1440
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
  • Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
  • WHO performance status (PS) 0-2
  • Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L
  • Life expectancy of at least 8 weeks

Exclusion Criteria:

  • Prior ZD1839 therapy
  • Prior docetaxel treatment for NSCLC
  • Less than 14 days since completion of prior radiotherapy
  • Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
  • Evidence of clinically active Interstitial Lung Disease
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
  • Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Canada,   China,   Croatia,   Denmark,   Estonia,   France,   Germany,   Hong Kong,   Indonesia,   Italy,   Latvia,   Malaysia,   Mexico,   Philippines,   Singapore,   Slovenia,   Spain,   Sweden,   Switzerland,   Thailand,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00076388
Other Study ID Numbers  ICMJE D791GC00001
EudraCT No: 2004-002943-28
1839IL/0721
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date May 2011

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