Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer
- Determine the recommended phase II dose of docetaxel and irinotecan in combination with
celecoxib in patients with advanced non-small cell lung cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the response rate of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate angiogenesis markers (intratumoral microvessel density and vascular
endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2
expression with response and survival in patients treated with this regimen.
- Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in
OUTLINE: This is a dose-escalation study of docetaxel and irinotecan.
- Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30
minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on
day 2. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and
irinotecan until the recommended phase II dose is determined. The recommended phase II
dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience
- Phase II: Patients receive treatment as in phase I at the recommended phase II dose.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will
be accrued for this study.
Primary Purpose: Treatment
Athanassios Argiris, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Evanston Northwestern Health Care - Evanston Hospital||Evanston, Illinois 60201|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Silver Cross Hospital||Joliet, Illinois 60432|