A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer
- Determine the biologically active dose of celecoxib administered with erlotinib in
patients with stage IIIB or IV non-small cell lung cancer.
- Determine the toxicity profile of this regimen in these patients.
- Determine the clinical activity of this regimen, in terms of reduction in tumor burden,
in these patients.
- Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor
receptor inhibition in patients treated with this regimen.
OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib.
Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28.
Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or responding disease may continue treatment
beyond 2 courses at the investigator's discretion.
Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated
dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.
Primary Purpose: Treatment
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|