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

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

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.

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.

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