Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer
- Compare the objective response or stable disease rate in elderly patients with
unresectable, progressive, metastatic colorectal cancer treated with irinotecan
hydrochloride with vs without capecitabine.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life and ability to maintain self-sufficiency of patients
treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to participating center, WHO performance status (0 or 1 vs 2), number of
associated comorbidities (Charlson index 0-2 vs > 2), and age (75-79 vs ≥ 80). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment
repeats every 2 weeks for 2 courses in the absence of disease progression or
- Arm II: Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV
over 90 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence
of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 12 weeks thereafter.
After completion of study therapy, patients are followed every 12 weeks.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Emmanuel Mitry, MD, PhD
Hopital Ambroise Pare
United States: Federal Government