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A Phase I Study of ZD1839 and Palliative Thoracic Radiotherapy in Patients With Non-small-cell Lung Cancer

Phase 1
Completed
Conditions
Non-small-cell Lung Cancer
Registration Number
NCT00255489
Lead Sponsor
AstraZeneca
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
To characterize the safety profile of ZD 1839 in these patients
Secondary Outcome Measures
NameTimeMethod
To measure the quality of life compared to baseline
To measure the change in disease related symptoms compared to baseline

Trial Locations

Locations (1)

Research Site

🇬🇧

Leeds, United Kingdom

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