Irinotecan Combined With Infusional 5-FU/Folinic Acid or Capecitabine and the Role of Celecoxib in Patients With Metastatic Colorectal Cancer
- Compare the progression-free survival of patients with metastatic colorectal cancer
treated with capecitabine and irinotecan vs fluorouracil, leucovorin calcium, and
irinotecan with vs without celecoxib.
- Compare the safety of these regimens in these patients.
- Compare the response rate in patients treated with these regimens.
- Compare the time to treatment failure and overall survival of patients treated with
OUTLINE: This is a randomized, double-blind*, multicenter study. Patients are stratified
according to participating center, prior adjuvant therapy (yes vs no), and risk group (poor
vs intermediate vs good). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive irinotecan IV over 30-90 minutes on days 1 and 22; oral
capecitabine twice daily on days 1-15 and 22-36; and oral celecoxib twice daily on days
- Arm II: Patients receive irinotecan and capecitabine as in arm I and oral placebo twice
daily on days 1-42.
- Arm III: Patients receive irinotecan IV over 30-90 minutes on days 1, 15, and 29;
leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV over 22 hours on
days 1, 2, 15, 16, 29, and 30; and oral celecoxib twice daily on days 1-42.
- Arm IV: Patients receive irinotecan, CF, and 5-FU as in arm III and oral placebo twice
daily on days 1-42.
In all arms, treatment repeats every 6 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity. If all chemotherapy is discontinued due to toxicity,
patients may continue celecoxib or placebo until disease progression, unacceptable toxicity,
or starting a new cytotoxic regimen.
NOTE: *The double-blind treatment only applies to the celecoxib and placebo randomization
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 692 patients (173 per treatment arm) will be accrued for this
study within 3.5 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Claus-Henning Koehne, MD
United States: Federal Government