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

Completed · Phase 2

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT00137800

Run by

Dana-Farber Cancer Institute

People needed

82

Starts

2003-02-01

Expected to finish

2007-03-01

Last updated by the study team

2020-04-03

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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