Back to resultsA Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer
Primary Purpose
Non-small-cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Gefitinib
palliative thoracic radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2 Histologically or cytologically conformed non-small cell lung cancer Aged 18 or over Exclusion Criteria: Previous thoracic radiotherapy Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event Known hypersensitivity to any component of study medication
Sites / Locations
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
To characterize the safety profile of ZD 1839 in these patients
Secondary Outcome Measures
To measure the quality of life compared to baseline
To measure the change in disease related symptoms compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00255489
Brief Title
A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer
Official Title
A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to characterize the safety profile of ZD1839 in combination with Palliative thoracic Radiotherapy in patients with non-small cell lung cancer
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 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Type
Procedure
Intervention Name(s)
palliative thoracic radiotherapy
Primary Outcome Measure Information:
Title
To characterize the safety profile of ZD 1839 in these patients
Secondary Outcome Measure Information:
Title
To measure the quality of life compared to baseline
Title
To measure the change in disease related symptoms compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent
Patients requiring low dose palliative thoracic irradiation to a field size of less than or equal to 150cm2
Histologically or cytologically conformed non-small cell lung cancer
Aged 18 or over
Exclusion Criteria:
Previous thoracic radiotherapy
Any condition that may pre-dispose the patient to suffer an individual drug-relaged DLT (dose limiting toxicity) event
Known hypersensitivity to any component of study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Iressa Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer
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