Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-26 @ 2:57 PM
Study NCT ID:
NCT00040768
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2002-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: