Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

Study Overview
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Brief Summary
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The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

Detailed Description
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Patients will receive OSI-774 once daily without interruption. There are no pre-determined number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and efficacy, a four week (28 day period) will be considered 1 cycle. Patients will continue to receive OSI-774 until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study. Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2, patients will also be evaluated by FDG-PET scanning. Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day of each cycle. Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.

Official Title
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A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: OSI-774 (Tarceva)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 70 years of age or older Stage IV or IIIB non-small cell lung cancer (NSCLC) Measurable tumor(s) Three or more weeks since prior radiation therapy Three or more weeks since prior major surgery Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities. Must be up and about more than 50% of waking hours. Life expectancy of 8 weeks or more Blood tests that show kidneys, liver and bone marrow to be working adequately Completely healed from previous oncologic or other major surgery Exclusion Criteria: Prior chemotherapy regimen for non-small cell lung cancer Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225, etc. Uncontrolled central nervous system metastases Concurrent active cancer Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin Prior chemotherapy for any malignant disease Difficulty swallowing A disease or disorder that interferes with ability to digest and absorb food A medical condition that could make it unsafe for patient to participate in this study

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Tarceva<br>Chemotherapy Single Agent Systemic | Drug: OSI-774 (Tarceva)<br>* Once daily without interruption as long as there is no disease progression or serious side effects experienced.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine how well non-small cell lung cancer cells in the body respond to OSI-774 |  | 2 years | 
| To determine the survival rate of patients treated with OSI-774 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of OSI-774 in people 70 years of age or older |  | 2 years | 
| To see how OSI-774 affects overall quality of life |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer, Elderly Cancer Patients, Tarceva, Erlotinib, OSI-774, Stage IIIB or IV Non-Small Cell Lung Cancer