Clinical Trials Directory

Trials / Completed

CompletedNCT00118144

Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer

Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

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

Summary

This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib. SECONDARY OBJECTIVES: I. Determine the progression-free and overall survival of patients treated with this drug. II. Determine the time to disease progression in patients treated with this drug. III. Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no). Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival.

Conditions

Interventions

TypeNameDescription
DRUGbortezomibGiven IV

Timeline

Start date
2005-06-01
Primary completion
2010-12-01
Completion
2010-12-01
First posted
2005-07-11
Last updated
2014-08-21
Results posted
2014-08-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00118144. Inclusion in this directory is not an endorsement.