Back to resultsPhase II Iressa + Irradiation Followed by Chemo in NSCLC
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Gefitinib
Radiation therapy
Cisplatin
Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research SIte
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00333294
Brief Title
Phase II Iressa + Irradiation Followed by Chemo in NSCLC
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Type
Procedure
Intervention Name(s)
Radiation therapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Primary Outcome Measure Information:
Title
To estimate the objective response rate in patients treated with this drug
Secondary Outcome Measure Information:
Title
Determine the safety and toxicity of this drug in these patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca France Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Clermont Ferrand
Country
France
Facility Name
Research Site
City
Grenoble
Country
France
Facility Name
Research Site
City
Nantes
Country
France
Facility Name
Research SIte
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Phase II Iressa + Irradiation Followed by Chemo in NSCLC
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