Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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