Phase II Trial of High-Dose Continuous Infusion 5-Fluorouracil with Allopurinol Modulation in Colon Cancer

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Abstract
Twenty patients with metastatic colon cancer without prior chemotherapy received 2 g/m2 of 5-fluorouracil (5-FU) infused over 24 h for 5 days preceded by allopurinol 900 mg orally for 1 week and then continued during, and for 1 week after the infusion was completed. Fourteen patients were evaluable for both response and toxicity. One patient (14%) achieved a partial response lasting 2 months. No significant hematologic toxicity was seen but 18 of 19 patients evaluable for toxicity developed mucositis resulting in dose reductions in 3 patients and refusal of a second course by 2 additional patients. 5-FU infusions with allopurinol as used in this regimen appear to offer no therapeutic advantage over a conventional dosing schedule.