Three-arm, randomized, phase 2 study of carboplatin and paclitaxel in combination with cetuximab, cixutumumab, or both for advanced non-small cell lung cancer (NSCLC) patients who will not receive bevacizumab-based therapy: An Eastern Cooperative Oncology Group (ECOG) study (E4508).

Cancer
Nasser HannaJ Schiller

Abstract

Preclinical evidence supports the clinical investigation of inhibitors to the insulin-like growth factor receptor (IGFR) and the epidermal growth factor receptor (EGFR) either alone or in combination as treatment for patients with non-small cell lung cancer (NSCLC). Patients with chemotherapy-naïve, advanced NSCLC who had an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible. Patients were randomized to receive carboplatin intravenously at an area under the plasma drug concentration-time curve of 6.0 plus paclitaxel 200 mg/m(2) intravenously on day 1 every 3 weeks combined with either intravenous cetuximab weekly (arm A), intravenous cixutumumab every 2 weeks (arm B), or both (arm C). Patients who had nonprogessing disease after 12 weeks of therapy were permitted to continue on maintenance antibody therapy until they developed progressive disease. The primary endpoint was progression-free survival (PFS). The study design required 180 eligible patients and had 88% power to detect a 60% increase in median PFS for either comparison (arm A vs arm C or arm B vs arm C) using the log-rank test. From September 2009 to December 2010, 140 patients were accrued. The study was closed to accrual early because of a...Continue Reading

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Citations

Nov 9, 2015·Cancer Treatment Reviews·Linda M HenricksJos H Beijnen
Mar 8, 2016·Expert Opinion on Biological Therapy·Tania LosannoCesare Gridelli
Sep 8, 2015·Cancer Metastasis Reviews·Gouji ToyokawaYukito Ichinose
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Mar 15, 2018·Expert Opinion on Biological Therapy·Luca MazzarellaGiuseppe Curigliano
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