A phase I study of continuous administration of 5-fluorouracil/cisplatin in advanced uterine cervical cancer

Background: The aim of this study was to assess the toxicity of a neoadjuvant chemotherapy (NAC) regimen consisting of cisplatin (CDDP) and 5-fluorouracil (5-FU) through 24-hour intravenous continuous infusion on days 1-4 in a Phase I study. Patients and Methods: Thirteen patients were recruited for this study. All patients were treated with a regimen consisting of CDDP and 5-FU through a 24-hour intravenous continuous infusion on days 1-4, followed by radical hysterectomy and/or radiation. Each initial dose of CDDP and 5-FU was 20mg/m(2)/day and 750mg/m(2)/day, respectively, for 4 days. Results and Conclusion: In the third step, seven patients were treated at 25mg/m(2) day CDDP and 1000mg/m(2)/day 5-FU, respectively, for 4 days. One of seven patients showed Grade 4 thrombopenia. However, in this dose step, all the patients showed an objective response. Although maximum tolerated doses (MTDs) were not reached, we decided to stop the escalation and to recommend this level for the Phase II study.