A phase II trial was performed to assess the safety and efficacy of the semisynthetic vinca alkaloid vinorelbine (VNR) when combined with carboplatin in recurrent and/or metastatic squamous cell carcinoma of the head and neck. Treatment consisted of VNR 30 mg/m2 in 250 ml saline, infused over 30 min on days 1 + 8, and carboplatin 300 mg/m2 in 1,000 ml saline, infused over 2 h on day 1. Treatment was continued in patients achieving objective response or stable disease for a total of 6 courses. 24 patients entered this trial, 12 of whom had received prior induction chemotherapy and radiation, 2 had palliative chemotherapy and 10 had only radiation and/or surgery. We observed 2 partial response (9.5%), stable disease in 6 patients (28.5%) and progressive disease in 13 (62%). The dose-limiting toxicity was myelosuppression with grade 3 or 4 leukocytopenia in 11 patients (46%). Thrombocytopenia was seen in only 2 patients. The most frequent nonhematological toxicity was an acute pain at the tumor site. None of the patients experienced neurological symptoms or chemically induced phlebitis. VNR combined with carboplatin does not appear to improve the therapeutic armentarium in recurrent squamous cell carcinoma of the head and neck.