This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells. .
PRIMARY OBJECTIVES: I. Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy. SECONDARY OBJECTIVES: I. Determine the time to progression in patients treated with this regimen. II. Determine the survival duration of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response, time to progression, and survival in patients treated with this regimen. OUTLINE: Patients are assigned to 1 of 2 treatment groups. Group 1: Patients receive oral erlotinib once daily and oral celecoxib twice daily. Group 2: Patients receive erlotinib as in group 1. Treatment in both groups continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 10 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Rush University Medical Center
Chicago, Illinois, United States
Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: From the start of treatment until disease progression/recurrence, assessed up to 5 years
Time to progression
Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.
Time frame: Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years
Overall survival
Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.
Time frame: Up to 5 years
Relationship between measures of treatment efficacy and EGFR and COX-2 levels
Time frame: Up to 5 years
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 5 years
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