Iressa 2nd Line Phase III Study in Japan - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252707

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 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 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

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

Show 40 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Japan Medical Director, MD

AstraZeneca

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52.

Study ID Numbers:	D791AL00001, V-15-32
Study First Received:	November 14, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00252707
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Gefitinib
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009