Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
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 defined as a confirmed CR or PR.
- Progression-free Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Progression Free Survival using the product-limit method of Kaplan and Meier
- Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Overall Suvival using the product-limit method of Kaplan and Meier.
|Study Start Date:||June 2005|
|Study Completion Date:||December 2010|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118144
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||David Gandara||City of Hope|