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

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Study Completion: 2006-06
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

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

Name	Time	Method
To characterize the safety profile of ZD 1839 in these patients

Secondary Outcome Measures

Name	Time	Method
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