CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV 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
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer|
- Confirmed tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
- Progression-free survival [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Computed and binomial confidence intervals for the true success proportion will be calculated.
- Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 5 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 5 years ] [ Designated as safety issue: No ]Estimated using the method of Kaplan-Meier.
- Effects of CCI-779 on mTOR as assessed by expression of 4EBP, phosphoAkt, p70S6kinase, eIF4E, cyclinD1, Her2, and EGFR [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22.
Other Names:Other: laboratory biomarker analysis
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 this drug.
II. Determine the time to progression and overall survival of patients treated with this drug.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079235
|United States, Minnesota|
|North Central Cancer Treatment Group|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Alex Adjei||North Central Cancer Treatment Group|