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

A Phase I Study of ZD1839 (Iressa) and Palliative Thoracic Radiotherapy in Patients With Non-small Cell Lung Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00255489

Enrollment

Registered

2005-11-21

Start date

2004-05-31

Completion date

2006-06-30

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell Lung Cancer

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

Interventions

DRUGGefitinib

PROCEDUREpalliative thoracic radiotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To characterize the safety profile of ZD 1839 in these patients	—

Secondary

Measure	Time frame
To measure the quality of life compared to baseline	—
To measure the change in disease related symptoms compared to baseline	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026