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Phase II Iressa + Irradiation Followed by Chemo in NSCLC

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ClinicalTrials.gov Identifier: NCT00333294
Recruitment Status : Completed
First Posted : June 5, 2006
Last Update Posted : December 19, 2007
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Gefitinib Procedure: Radiation therapy Drug: Cisplatin Drug: Vinorelbine Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer
Study Start Date : September 2004
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources




Primary Outcome Measures :
  1. To estimate the objective response rate in patients treated with this drug

Secondary Outcome Measures :
  1. Determine the safety and toxicity of this drug in these patients


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • 18 to 75 years inclusive.
  • At least one measurable lesions histologically confirmed inoperable stage III NSCLC.
  • WHO performance status of 0 to 2 inclusive.
  • Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %.
  • Life expectancy of at least 6 months.
  • Using secure contraceptives precautions.

Exclusion Criteria:

  • Any previous anti cancer therapy for NSCLC.
  • Known severe hypersensitivity to these products
  • Any evidence of clinically active interstitial lung disease
  • Other co-existing malignancies, symptomatic metastases.
  • Abnormal blood test
  • Weight loss of over 15% in the 3 months before the start of the study.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

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): NCT00333294


Locations
France
Research Site
Clermont Ferrand, France
Research Site
Grenoble, France
Research Site
Nantes, France
Research SIte
Paris, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00333294     History of Changes
Other Study ID Numbers: 1839IL/0530
First Posted: June 5, 2006    Key Record Dates
Last Update Posted: December 19, 2007
Last Verified: December 2007

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