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

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Drug: OSI-774 (Tarceva)

• Registration Number: NCT00137800
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-05
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Study Completion: 2007-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tarceva	OSI-774 (Tarceva)	Chemotherapy Single Agent Systemic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States