Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Phase II Trial of OSI-774 (NSC-718781) in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PRIMARY OBJECTIVES:
I. To assess survival in patients with advanced non-small cell lung carcinoma with a Zubrod
Performance Status of 2 treated with OSI-774.
II. To evaluate the objective tumor response rates (confirmed plus unconfirmed, complete and
partial), in patients with advanced non-small cell lung carcinoma with a Zubrod Performance
Status of 2 treated with OSI-774.
III. To investigate in a preliminary manner possible correlations of EGFR expression,
mutations, and/or EGFR polymorphisms with response and/or survival.
IV. To investigate in a preliminary manner possible correlations of activated signal pathway
molecules, including basal p27 expression levels with response and/or survival.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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