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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
April 1, 2002
Primary Completion Date
March 1, 2006
Last Updated
January 16, 2013
35
ACTUAL participants
bortezomib
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT02889666
NCT02495896
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04056247