A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
- Compare the efficacy of different schedules of irinotecan in combination with
capecitabine as first-line therapy, in terms of objective response rate, in patients
with advanced or metastatic colorectal cancer.
- Compare the time to treatment failure, time to progression, and overall survival of
patients treated with these regimens.
- Compare the safety profile, in terms of toxicity, of these regimens in these patients.
- Determine the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of
appetite, malaise, and fever of unknown origin (yes vs no); weight loss during the past 6
months (more than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6
months or less). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral
capecitabine twice daily on days 1-14 and 22-35.
- Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral
capecitabine as in arm I.
Treatment in both arms repeats every 6 weeks in the absence of disease progression or
Quality of life is assessed at baseline, on day 1 of each course, and at the first visit
after treatment failure.
Patients are followed every 12 weeks for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per treatment arm) will be accrued for
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Markus M. Borner, MD
University Hospital Inselspital, Berne