Phs. II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients W/Advanced Stage or Inoperable Non-Small Cell Lung Cancer (NSCLC)
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The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. We would also like to estimate disease-related symptom improvement rates using a questionnaire.
Condition or disease
Non-Small Cell Lung Cancer
Drug: Erlotinib (drug)
In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).
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Ages Eligible for Study:
65 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have confirmed non-small cell lung cancer. Age > 65 years Patients must have adequate organ and marrow function
Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.