ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.

Detailed Description
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To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response. To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.

Official Title
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A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Carcinoma (NSCLC)

Intervention / Treatment
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* Drug: ZD1839 (Iressa)
* Radiation: Thoracic Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed non small cell lung cancer Stage IV needing radiation therapy to control symptoms Patients with brain metastases Unresectable or medically inoperable Exclusion Criteria: Small cell lung cancer Previous thoracic radiation therapy Oxygen-dependent patients Forced expiratory volume in 1 second (FEV1) less than 1.5 Patients with active interstitial lung disease Patients with underlying lung disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iressa and RT<br>Iressa plus thoracic RT at the following dose levels: Level 1: 42.0 Gy in 10 fractions of 4.2 Gy Level 2: 50.4 Gy in 12 fractions of 4.2 Gy Level 3: 63.0 Gy in 15 fractions of 4.2 Gy | Drug: ZD1839 (Iressa)<br> <br> Radiation: Thoracic Radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Affected by Treatment-related Morbidities | See Adverse Events section for specific toxicities | Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response | Definitions of objective tumor response Complete response - disappearance of all target lesions Partial response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Progressive disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started | Baseline, 1, 3, and 5 months post-treatment | 
| Progression-free Survival |  | Baseline to date of progression | 
| Survival From Starting Gefitinib |  | Baseline to date of expiration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced NSCLC, Non-Small Cell Lung Carcinoma, Stage IV NSCLC