Open-label, single-arm phase II study of pemetrexed in the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma who have had prior platinum-based chemotherapy

This study was designed to evaluate the anti-tumor activity and toxicity of single agent pemetrexed in the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who had been treated with platinum-based chemotherapy. This is an open-label, single-arm phase II trial. All patients were treated with pemetrexed. Pemetrexed was given at the dosage of 500 mg/m(2) on day 1, with folic acid and vitamin B12 supplementation, each cycle repeated every 3 weeks. Treatment continued until patient had disease progression or unacceptable toxicities. Thirty-five patients were enrolled in this trial. Thirty patients of total were suitable for tumor response assessment. One (2.9 %) patient achieved partial response (PR); 14 (40.0 %) patients, stable disease (SD); and 15 (42.9 %), progressed disease (PD). The progress-free survival (PFS) was 1.5 months (range, 1.5-14.4 months) and median overall survival (OS) was 13.3 months (95 % CI 8.2-18.4 months). Treatment was well tolerated in most patients. Only one patient (2.9 %) experienced grade 4 toxicity of thrombocytopenia and neutropenia. The most seen toxicities were neutropenia (37.1 %), aminotransferase increase (31.4 %), and rash (22.9 %). Although pemetrexed induced a response in a patient, it has limited single-agent activity in advanced NPC patients pretreated with platinum-based chemotherapy.