Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate with bortezomib evaluated by both RECIST criteria and computer-assisted image analysis.
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.
Up to 5 years
City of Hope Medical Center
United States: Food and Drug Administration
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