Poor accrual

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