PMID: 11332149May 3, 2001Paper

A phase I study of a fixed dose of cisplatin with increasing doses of raltitrexed (Tomudex) in the treatment of patients with locally advanced or metastatic squamous cell carcinoma of the head and neck

Annals of Oncology : Official Journal of the European Society for Medical Oncology
D ten Bokkel HuininkH J Keizer

Abstract

A phase I trial of raltitrexed in combination with cisplatin in patients with locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN). Eligible patients had locally advanced or metastatic SCCHN. Cohorts of patients were treated with escalating doses of raltitrexed (2.0 mg/m2 to 3.5 mg/m2) as a 15-minute intravenous infusion immediately followed by cisplatin (80 mg/m2) administered over four hours every three weeks to determine the maximum tolerated dose (MTD). A total of 17 patients was administered 60 courses of an escalating dose of raltitrexed. Starting dose of cisplatin was initially 100 mg/m2 in the first three patients treated at the first dose level. Due to cisplatin-induced nephrotoxicity expressed as a creatinine clearance decrease by more than 50%, the cisplatin dose was reduced to 80 mg/m2 for all subsequent treatment cycles. Dose-limiting toxicity was observed at raltitrexed dose of 3.5 mg/m2 in two out of five patients. Dose-limiting grade 4 (CTC) neutropenia, grade 4 diarrhoea, grade 3 lethargy and elevation of transaminases and bilirubine was seen in these two patients. One patient treated at the level of the MTD, died 23 days after the first cycle with unresolved gastro-intestinal tox...Continue Reading

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