Iressa 2nd Line Phase III Study in Japan

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252707
First received: November 14, 2005
Last updated: December 14, 2007
Last verified: December 2007
  Purpose

In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Gefitinib or 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 Multicentre, Randomised, Open-Label, Parallel-Group, Phase III Post-Marketing Clinical Study to Compare the Overall Survival Between Gefitinib and Docetaxel in Patients With Advanced or Metastatic (Stage IIIB/IV), or Recurrent Non-Small Cell Lung Cancer, Who Have Failed One or Two Chemotherapy Regimens

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Determine the overall survival with these treatments as the primary outcome.

Secondary Outcome Measures:
  • Determine the followings as the secondary outcome variables:
  • - Progression-free survival (PFS)
  • - Time to treatment failure (TTF)
  • - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [≥12 weeks]) based on the RECIST guidelines
  • - Lung cancer subscale (LCS)
  • - QOL according to FACT-L questionnaire
  • - Frequency and severity of adverse events.
  • Determine the followings as the exploratory outcome variables:
  • - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways
  • - Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells.

Estimated Enrollment: 484
Study Start Date: September 2003
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC
  • You have been treated with chemotherapy including platinums for NSCLC.

Exclusion Criteria:

  • You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies)
  • You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray
  • You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252707

Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Okazaki, Aichi, Japan
Research Site
Hirosaki, Aomori, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyogo, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Naka-gun, Ibaraki, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Omura, Nagasaki, Japan
Research Site
Beppu, Oita, Japan
Research Site
Habikino, Osaka, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Osakasayama, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Iwata, Shizuoka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
Research Site
Chuo, Tokyo, Japan
Research Site
Kiyose, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Sumida, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Fukuoka, Japan
Research Site
Gifu, Japan
Research Site
Kanazawa, Japan
Research Site
Kumamoto, Japan
Research Site
Nagasaki, Japan
Research Site
Niigata, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Yamagata, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00252707     History of Changes
Other Study ID Numbers: D791AL00001, V-15-32
Study First Received: November 14, 2005
Last Updated: December 14, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014