NCT00040768

Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer

A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	bortezomib	Given IV

Timeline

• Start date: 2002-04-01
• Primary completion: 2006-03-01
• First posted: 2003-01-27
• Last updated: 2013-01-16

Locations

1 site across 1 country: United States