Low-dose continuous infusion 5-fluorouracil and cisplatin: phase II evaluation in advanced colorectal carcinoma

A study was performed to evaluate the combination of low-dose continuous infusion 5-fluorouracil (LDCI-FU) (300 mg/m2 daily for 28 days) and cisplatin (20 mg/m2 days 1-5 and 24-28). Patients were treated for 28 days with a subsequent 14-day rest period. A total of 24 patients were entered on the study and were evaluable for response and toxicity. All patients were previously untreated, with a median age of 61.5 years and median performance status of 70% (Karnofsky). Bidimensional measurable disease was required. Complete responses were noted in 2 of 24 (8%) patients lasting 8+ and 9 months. Partial responses were observed in 8 of 24 (33%), with a median duration of response of 6 months. Median survival for the 24 patients was 9+ months. Toxicities included nausea and vomiting (25%), hand-foot syndrome (21%), diarrhea (4%), myelosuppression (21%), neurotoxicity (13%), gastric ulceration (13%), mucositis (17%), nephrotoxicity (4%), and subclavian vein thrombosis (21%). This combination demonstrated antineoplastic activity; however, its efficacy parallels other trials utilizing both single agent 5-fluorouracil (5-FU) and different variations of the 5-FU/cisplatin in combination. The impact of this combination on survival and comparison to other regimens requires a randomized trial.