Cisplatin and infusional cytosine arabinoside for the treatment of colorectal adenocarcinoma: A phase II trial

Based on the in vitro and in vivo synergy between cytosine arabinoside (Ara -C) and cis-diamminedichloroplatinum (cisplatin), we designed a phase II tr ial of Ara-C with cisplatin for patients with colorectal adenocarcinoma. Fo rty-eight eligible patients received continuous infusion Ara-C, 30 mg/m(2)/ day over 72 hr, plus cisplatin, 30 mg/m(2) for three doses at hours 12, 36, and 50 of the Ara-C infusion. The objective partial response rate for pati ents with colon carcinoma was 3% (1/32 patients; 95% CI, 0-16%) with a medi an response duration of 2.8 months. None of the 16 patients treated for rec tal carcinoma responded. Myelosuppression was the most severe toxicity. Sig nificant gastrointestinal and hepatic toxicities occurred in a small number of patients. Nephrotoxicity and neurotoxicity were mild. We conclude that the prolonged infusion of Ara-C in combination with divided closes of cispl atin offers no significant therapeutic advantage.