Non-Small-Cell Lung Carcinoma Clinical Trial
Official title:
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.
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