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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: Gefitinib Drug: Docetaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To compare overall survival between ZD1839 and docetaxel

Secondary Outcome Measures :
  1. To compare time to progression (TTP) between ZD1839 and docetaxel
  2. To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
  3. To compare the overall objective tumor response rate between ZD1839 and docetaxel
  4. To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
  5. To compare safety and tolerability of ZD1839 and docetaxel

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076388


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00076388    
Other Study ID Numbers: D791GC00001
EudraCT No: 2004-002943-28
1839IL/0721
First Posted: January 23, 2004    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: May 2011
Keywords provided by AstraZeneca:
Non-Small-Cell Lung Cancer
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Docetaxel
Gefitinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors