Phase II trial to study the effectiveness of bortezomib in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer. Bortezomib may interfere with the growth of tumor cells by blocking certain enzymes necessary for tumor cell growth
PRIMARY OBJECTIVES: I. Determine the response rate, time to progression, and survival of patients with advanced non-small cell lung cancer treated with bortezomib. II. Determine the toxicity of this drug in these patients. III. Correlate toxicity and activity of this drug with markers of proteasome inhibition in blood and peripheral mononuclear cells in these patients. OUTLINE: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Overall response rate to PS-341 therapy
Time frame: Up to 4 years
Progression-free survival
Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.
Time frame: Up to 4 months
Overall survival
Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.
Time frame: Up to 4 hours
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