Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
|ClinicalTrials.gov Identifier: NCT00118144|
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : August 21, 2014
Last Update Posted : August 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: bortezomib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.
- Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis. [ Time Frame: Up to 5 years ]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 ]Progression Free Survival using the product-limit method of Kaplan and Meier
- Overall Survival [ Time Frame: Up to 5 years ]Overall Suvival using the product-limit method of Kaplan and Meier.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118144
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||David Gandara||City of Hope Medical Center|