Iressa Versus Docetaxel (Taxotere)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: January 21, 2004
Last updated: May 12, 2011
Last verified: May 2011

January 21, 2004
May 12, 2011
February 2004
March 2007   (final data collection date for primary outcome measure)
To compare overall survival between ZD1839 and docetaxel
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Complete list of historical versions of study NCT00076388 on Archive Site
  • 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
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Iressa Versus Docetaxel (Taxotere)
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
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.
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Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
  • Drug: Gefitinib
  • Drug: Docetaxel
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2007
March 2007   (final data collection date for primary outcome measure)

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)
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   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
D791GC00001, EudraCT No: 2004-002943-28, 1839IL/0721
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Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
May 2011

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