A Randomized, Placebo-Controlled Phase II Clinical Trial of Combination Erlotinib (Tarceva) and Celecoxib (Celebrex) Versus Erlotinib (Tarceva)/Placebo in Advanced Non-Small Cell Lung Cancer Patients
PRIMARY OBJECTIVES:
I. Comparison of progression-free survival (PFS) in patients receiving erlotinib + celecoxib
vs. erlotinib + placebo for advanced NSCLC.
SECONDARY OBJECTIVES:
I. Objective tumor response rate as defined by RECIST Criteria for subjects receiving
erlotinib/celecoxib treatment arms.
II. Categorize the change in e-cadherin expression from baseline to week 8 in a subset of
subjects.
III. Evaluation of overall survival (OS). IV. Measurement of COX-2, EGFR by
immunohistochemistry and EGFR amplification by FISH, and EGFR mutation status to correlate
with clinical response.
V. Measurement of change in urinary PGE-M and correlation with response.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily
on days 1-28.
ARM II: Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice
daily on days 1-28.
In both arms, treatment repeats every 28 days for 12 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression-free survival
1 year post treatment
No
Karen Reckamp
Principal Investigator
Beckman Research Institute
United States: Food and Drug Administration
06254
NCT00499655
June 2007
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |
South Pasadena Cancer Center | South Pasadena, California 91030 |