This clinical trial is studying how well erlotinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES: I. Prospectively identify downstream markers of EGFR linked signaling pathways that are predictive of response to OSI-774 (Erlotinib) in this population. SECONDARY OBJECTIVES: I. Estimate antitumor objective response rate per RECIST. II. Estimate disease control rate (CR+PR+SD). III. Estimate time to progression and overall survival. IV. Estimate if a grade 2 rash is a predictor of response to OSI-774 (Erlotinib) and of patient survival. V. Assess safety profile of OSI-774 (Erlotinib) in this population. VI. To determine whether smoking status is linked to outcome for advanced NSCLC patients treated with OSI-774 (Erlotinib). OUTLINE: This is a pilot, multicenter study. Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment. After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study within 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Given orally
Correlative studies
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States
Response rates and distribution of the mitogen-activated protein kinase (MAPK)/extracellular-signal-regulated kinase (Erk)-phosphorylated expression groups based on the Response Evaluation Criteria in Solid Tumors (RECIST)
A Fisher's exact test with a two-sided 5% type I error rate will be calculated.
Time frame: Up to 5 years
Objective response rate based on the RECIST
Time frame: Up to 5 years
Disease control rate (complete response [CR]+partial response [PR]+stable disease [SD])
Time frame: Up to 8 weeks
Time to progression
Time frame: Date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, up to 5 years
Overall survival
Time frame: Up to 5 years
Toxicities associated with erlotinib hydrochloride, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Time frame: Up to 5 years
Relationship between clinical response and each of the markers using the semiquantitative histo-score method
Cox regression models will be used.
Time frame: Baseline
Effects of smoking status in terms of disease and survival
Descriptive and summary statistics will be conducted on the smoking questionnaire data.
Time frame: Up to 5 years
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