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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Once daily without interruption as long as there is no disease progression or serious side effects experienced.
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
To determine how well non-small cell lung cancer cells in the body respond to OSI-774
Time frame: 2 years
To determine the survival rate of patients treated with OSI-774
To determine the safety of OSI-774 in people 70 years of age or older
Time frame: 2 years
To see how OSI-774 affects overall quality of life
Time frame: 2 years
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