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
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.

Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
Drug: Gefitinib
Drug: Docetaxel
Phase 3

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, 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare overall survival between ZD1839 and docetaxel

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1440
Study Start Date: February 2004
Study Completion Date: October 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

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

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00076388

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Sponsors and Collaborators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00076388     History of Changes
Other Study ID Numbers: D791GC00001  EudraCT No: 2004-002943-28  1839IL/0721 
Study First Received: January 21, 2004
Last Updated: May 12, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 26, 2016