Lung Cancer Clinical Trial
Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
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.
Full 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.
Eligibility 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
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There are 2 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
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