Phase II Iressa + Irradiation Followed by Chemo in NSCLC

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00333294
First received: June 2, 2006
Last updated: December 16, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00333294     History of Changes
Other Study ID Numbers: 1839IL/0530
Study First Received: June 2, 2006
Last Updated: December 16, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Vinorelbine
Gefitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014