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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Genentech, Inc.; Massachusetts General Hospital
• Treatments: Erlotinib Hydrochloride

Criteria

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