A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer
OBJECTIVES: Primary I. Determine the response rate in patients with stage IIIB (with pleural
effusion) or IV non-small cell lung cancer treated with CCI-779.
II. Determine the clinical toxic effects of this drug in these patients.
Secondary I. Determine the 24-week progression-free survival rate in patients treated with
II. Determine the time to progression and overall survival of patients treated with this
III. Evaluate predictive markers of activity (e.g., PTEN mutations and phosphoAkt
expression) of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 25-55 patients will be accrued for this study within 12
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Up to 5 years
North Central Cancer Treatment Group
United States: Food and Drug Administration
|North Central Cancer Treatment Group||Rochester, Minnesota 55905|