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NCT00255489 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00255489
Other study ID # 1839IL/0524
Secondary ID
Status Completed
Phase Phase 1
First received November 17, 2005
Last updated January 24, 2011
Start date May 2004
Est. completion date June 2006

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gefitinib

Procedure:
• palliative thoracic radiotherapy

Locations
Country Name City State
United Kingdom Research Site Edinburgh
United Kingdom Research Site Leeds

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome
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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