Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
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
Adenocarcinoma of the Lung
Bronchoalveolar Cell Lung Cancer
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features|
- Objective response rate with bortezomib evaluated by both RECIST criteria and computer-assisted image analysis. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response rates will be separately summarized and the planned phase II decision rules will be separately applied to the two strata. Fisher's exact test comparing strata will be calculated, recognizing that this test has limited power with phase II sample sizes. A bivariate 95% confidence region will be calculated for the response rate in the two strata, as a means of jointly evaluating the strata.
- Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.
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.
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.
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: David R. Gandara 916-734-3771 email@example.com|
|Principal Investigator: David R. Gandara|
|Principal Investigator:||David Gandara||City of Hope Medical Center|