Spots Global Cancer Trial Database for Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

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Trial Identification

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

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

Study ID: NCT00137800

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

OSI-774 (Tarceva)

Study Description

Brief 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.

Detailed 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.