Pilot phase II study of gemcitabine and vinorelbine in patients with recurrent or refractory small cell lung cancer.

The aim of this phase II study was to evaluate toxicity, response, time to progression, and overall survival in patients with recurrent or progressive small cell lung cancer (SCLC) receiving the combination of gemcitabine and vinorelbine. This two stages Simon design trial was stopped after 17 patients were enrolled and response rate did not reach a level to justify continuation to the second stage. One patient had received three previous chemotherapy combinations, 5 had two prior chemotherapy regimens, and the remaining 11 had been treated with one prior line of therapy. Their median age was 62 years (35-72). Vinorelbine was administered at 25 mg/m(2) followed by gemcitabine 1000 mg/m(2), on days 1 and 8, every 3 weeks. Sixteen patients were evaluable for toxicity and 11 for response. Grade 3 neutropenia was seen in 5 patients (33%) and 3 patients had grade 4 neutropenia (20%). Three patients had grade 3 thrombocytopenia. No grade 4 non-hematological toxicities were seen. A total of 85 infusions were given, with 1 patient (6%) obtaining a partial response (PR) for a duration of 148 days. Three additional patients had stable disease (19%), but only in 1 patient for longer than 24 weeks. The median time to progression was 47 days for all patients (range 25-196). After a median follow-up of 184 days, 13 patients died (76%). Median overall survival was 164 days. The combination of gemcitabine and vinorelbine has limited activity in relapsed SCLC.