Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer

The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Inclusion Criteria: Histologically proven adenocarcinoma of colon and rectum No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy Advanced, metastatic or recurrent not amenable to curative local therapy Measurable lesion(s) ECOG performance status 0 to 2 Normal marrow, hepatic and renal function Provision of written informed consent Exclusion Criteria: Active infection and/or severe comorbidity Known history of anaphylaxis of any origin