A Phase II Study of OSI 774 (IND Number 63383) in Combination With Celecoxib (Celebrex, Pharmacia) as Second-Line Therapy in Advanced Non-Small Cell Lung Cancer
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.
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
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 10
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
From the start of treatment until disease progression/recurrence, assessed up to 5 years
Rush University Medical Center
United States: Food and Drug Administration
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