Non-small-cell Lung Cancer Clinical Trial
Official title:
A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer
Verified date | January 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Department of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 36 |
Est. completion date | June 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Research Site | Edinburgh | |
United Kingdom | Research Site | Leeds |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To characterize the safety profile of ZD 1839 in these patients | |||
Secondary | To measure the quality of life compared to baseline | |||
Secondary | To measure the change in disease related symptoms compared to baseline |
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