NCT00255489
Completed
Phase 1
A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer
ConditionsNon-small-cell Lung Cancer
DrugsGefitinib
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non-small-cell Lung Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- To characterize the safety profile of ZD 1839 in these patients
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
To characterize the safety profile of ZD 1839 in these patients
Secondary Outcomes
- To measure the quality of life compared to baseline
- To measure the change in disease related symptoms compared to baseline
Study Sites (1)
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