This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib. II. Determine the clinical toxic effects of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the 24-week progression-free survival rate in patients treated with this drug. II. Determine the overall survival of patients treated with this drug. III. Determine the time to disease progression in patients treated with this drug. IV. Correlate predictive disease markers (K-ras and B-raf mutations and ERK/pERK, AKT/pAKT, and VEGFR2/p-VEGFR2 expression) in these patients with the activity of this drug. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Given orally
Correlative studies
North Central Cancer Treatment Group
Rochester, Minnesota, United States
Confirmed tumor response according to RECIST criteria
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Time frame: Up to 5 years
Progression-free survival
The proportion of patients who are progression-free at 24-weeks will be computed and binomial confidence intervals for the true success proportion will be calculated.
Time frame: At 24 weeks
Survival time
Estimated using the method of Kaplan-Meier.
Time frame: From registration to death due to any cause, assessed up to 5 years
Time-to-disease progression
Estimated using the method of Kaplan-Meier.
Time frame: From registration to documentation of disease progression, assessed up to 5 years
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