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

AstraZeneca36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small-cell Lung Cancer

Interventions

GefitinibDRUG

palliative thoracic radiotherapyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Edinburgh, United Kingdom

Research Site

Leeds, United Kingdom

Outcomes

Primary Outcomes

To characterize the safety profile of ZD 1839 in these patients

Secondary Outcomes

To measure the quality of life compared to baseline

To measure the change in disease related symptoms compared to baseline

Data from ClinicalTrials.gov

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