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Iressa Versus Docetaxel (Taxotere)
This study has been completed.
First Received: January 21, 2004   Last Updated: January 15, 2009   History of Changes
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00076388
  Purpose

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 III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel ZD1839
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076388

  Show 162 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 1839IL/0721, EudraCT No: 2004-002943-28, D791GC00001
Study First Received: January 21, 2004
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00076388     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gefitinib
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009