This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib. SECONDARY OBJECTIVES: I. Determine the progression-free and overall survival of patients treated with this drug. II. Determine the time to disease progression in patients treated with this drug. III. Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no). Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Given IV
City of Hope
Duarte, California, United States
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.
A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.
Time frame: Up to 5 years
Progression-free Survival
Progression Free Survival using the product-limit method of Kaplan and Meier
Time frame: Up to 5 years
Overall Survival
Overall Suvival using the product-limit method of Kaplan and Meier.
Time frame: Up to 5 years
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