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BACKGROUND The objective of this multicenter, open-labeled, Phase II study performed in Spain was to assess the efficacy and safety of irinotecan (CPT-11) as first-line chemotherapy for patients suffering from advanced colorectal carcinoma (CRC). METHODS Patients with histologically proven CRC and at least one bidimensionally measurable lesion, ages 18–70 years, with a performance status ≤ 2, normal analytical values, and no prior chemotherapy or only adjuvant chemotherapy completed before study entry were selected. The treatment schedule was CPT-11 350 mg/m2 intravenously administered once every 3 weeks. Both tumor response and toxicity were assessed using the World Health Organization and National Cancer Institute common toxicity criteria. Changes in performance status, weight, and symptoms also were measured. RESULTS Sixty-five patients (44 chemotherapy-naive patients and 21 patients who completed prior adjuvant treatment) were enrolled. Of these, 24.7% of patients responded to the treatment, and 41.5% of patients had stable disease. Patients who had not received prior adjuvant chemotherapy had a lower rate of progression on therapy (27.3%) compared with those who had received prior adjuvant chemotherapy (42.9%). The median survival was 19.9 months (range, 0.3–29.3 months). No significant differences were found in the median survival between chemotherapy-naive patients and patients who had received previous chemotherapy. Grade 3–4 diarrhea and neutropenia were the most frequent severe toxic events, which were observed in 23.1% and 30.8% of patients and in 5.9% and 10.9% of the cycles, respectively. CONCLUSIONS The current antitumor efficacy results show that 350 mg/m2 of CPT-11 administered every 3 weeks is an active and feasible first-line chemotherapy regimen for patients with CRC. Finally, the overall safety data confirmed that CPT-11 is a well tolerated treatment. Cancer 2001;91:704–11. © 2001 American Cancer Society.