Phase II study of weekly paclitaxel for relapsed and refractory small cell lung cancer.

The purpose of this study was to evaluate the efficacy and toxicity of single-agent paclitaxel given weekly to patients with relapsed and refractory small cell lung cancer (SCLC). Patients were treated with 80 mg/m2 paclitaxel administered weekly for 1 h for 6 weeks in an 8-week cycle. Twenty-two patients were enrolled, 21 of whom were eligible. The patient characteristics included: 20 males, 1 female; median age 66 years (range 48-75); performance status 0/1 in 19 and 2 in 5 patients. Grade 3/4 leukopenia and neutropenia occurred in 47.5% and 64%, respectively. Other grade 3/4 toxicities included infection, skin rash, neuropathy and pulmonary toxicity. There were 5 partial responses in 3 out of the 11 sensitive cases and 2 out of the 10 refractory cases, respectively. Paclitaxel, administered as a weekly infusion at a dose of 80 mg/m2, was effective in treating relapsed and refractory SCLC.