Phase 2 trial of pemetrexed disodium and carboplatin in previously untreated extensive-stage small cell lung cancer, N0423

BACKGROUND: In extensive-stage small cell lung cancer (SCLC), the combination of pemetrexed plus carboplatin has shown activity and appeared to be well-tolerated We conducted a trial to confirm the efficacy and to assess the tolerability of this chemotherapy combination METHODS: Patients with untreated extensive-stage SCLC were enrolled in this phase 2 open-labeled study They receive pemetrexed 500 mg/m(2) and carboplatin (area under the curve of 5) every 21 days for a maximum 6 cycles The primary endpoint for this trial was the confirmed response rate and the accrual goal was 70 patients RESULTS: Forty-six eligible patients (29 aged <70 years, 17 aged >= 70 years) were accrued to this study The efficacy outcomes were similar between the 2 age groups Overall, the confirmed response rate was 35% (16 of 46, 95% confidence interval [CI], 21%-50%), where all 16 were partial responses On the basis of these results, we had strong evidence that the study would not meet the preset efficacy criteria and was, therefore, closed before full accrual The median duration of response was 4 4 months (95% Cl, 2 9-5 2). Median overall survival for patients aged <70 years and aged >= 70 years was 9 2 months (95% Cl, 5 4-11 6) and 108 months (95% CI, 2 2-14 3), respectively Grade 3 or higher toxicity rates were similar between the younger and older patients Grade 3/4 and grade 4 hematological toxicities were observed in 46% and 26% of patients, respectively CONCLUSIONS: Although well-tolerated the combination of pemetrexed and carboplatin is not as effective as standard therapy in patients with untreated extensive-stage SCLC Cancer 2010;116:2382-9. (C) 2010 American Cancer Society