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Phase II Iressa + Irradiation Followed by Chemo in NSCLC

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333294
First Posted: June 5, 2006
Last Update Posted: December 19, 2007
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Non-Small Cell Lung Cancer Drug: Gefitinib Procedure: Radiation therapy Drug: Cisplatin Drug: Vinorelbine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 50
Study Start Date: September 2004
Study Completion Date: January 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00333294     History of Changes
Other Study ID Numbers: 1839IL/0530
First Submitted: June 2, 2006
First Posted: June 5, 2006
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