A Phase I Study of Irinotecan in Combination With Fixed Dose Celecoxib in Patients With Advanced Colorectal Cancer
- Determine the maximum tolerated dose of irinotecan when administered with celecoxib in
patients with unresectable or metastatic colorectal cancer.
- Determine the dose-limiting toxic effects and non-dose-limiting toxic effects of this
regimen in these patients.
- Determine the incidence and intensity of diarrhea and myelotoxicity in patients treated
with this regimen.
- Determine any responses in patients treated with this regimen.
- Determine potential mechanisms for irinotecan-induced diarrhea and protective effects
of celecoxib on diarrhea prevention in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan. Patients are assigned to 1 of 2
- Group I: Patients receive a fixed dose of irinotecan IV over 90 minutes on days 1, 8,
15, and 22 and oral celecoxib twice daily on days 10-42. Courses repeat every 42 days
in the absence of disease progression or unacceptable toxicity.
- Group II: Patients receive irinotecan as in group I at escalating doses and oral
celecoxib twice daily on days 0-42. Treatment continues as in group I.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-30 patients (9 for group I, 9-21 for group II) will be
accrued for this study within 1-2 years.
Primary Purpose: Treatment
Marwan Fakih, MD
Roswell Park Cancer Institute
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|