A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine how well non-small cell lung cancer cells in the body respond to OSI-774
Pasi A Janne, MD, PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|