Paclitaxel and carboplatin in relapsed or metastatic nasopharyngeal carcinoma: a multicenter phase II study.

PURPOSE: This multicenter phase II study was conducted to investigate the activity and toxicity of a combination of paclitaxel and carboplatin delivered on an outpatient basis in relapsed/ metastatic nasopharyngeal carcinoma patients. PATIENTS AND METHODS: Patients aged>/= 18 years with histologically proven recurrent or metastatic nasopharyngeal carcinoma, an Eastern Cooperative Oncology Group (ECOG) performance status /= 12 weeks were eligible. Measurable disease outside prior radiotherapy ports was required, unless a subsequent progression of the lesion was documented. An interval of >/= 12 months was required between the previous chemotherapy (neoadjuvant, concurrent chemoradiotherapy or adjuvant) and study entry. Prior radiotherapy or surgery were allowed. All patients had adequate bone marrow (WBC >4000/mL, platelets >100000/mL), hepatic (bilirubin <1,5 mg/dL, SGPT <1.5xN), and renal function (serum creatinine <1.5 mg/dL or creatinine clearance >60 mL/min). Chemotherapy consisted of paclitaxel 175 mg/m(2), given as a 3-hour infusion, followed by carboplatin dosed to an area under the concentration- time curve (AUC) of 6 mg*min/mL, administered every 21 days. RESULTS: 40 patients entered the study. There were 3 complete responders (CR) and 8 partial responders (PR), for an overall response rate (ORR) of 27.5% (95% confidence interval - C.I.: 14.5-44). Median time to progression (TTP) was 3.5 months, and median survival was 11.5 months. Grade 3-4 toxicity included leucopenia (17.5% of the patients), anaemia (17.5%), thrombocytopenia (10%), neutropenia (7.5%), and peripheral neuropathy (2.5%). CONCLUSION: These data indicate that the combination of paclitaxel and carboplatin can be safely administered on an outpatient basis, but it is only moderately active against relapsed/metastatic nasopharyngeal carcinoma patients.