Phase I/II Trial of Weekly Intravenous 130-nm Albumin-Bound Paclitaxel As Initial Chemotherapy in Patients With Stage IV Non–Small-Cell Lung Cancer

作者: Naiyer A. Rizvi , Gregory J. Riely , Christopher G. Azzoli , Vincent A. Miller , Kenneth K. Ng

DOI: 10.1200/JCO.2007.10.8605

关键词:

摘要: Purpose Nanoparticle albumin-bound paclitaxel (NAB-paclitaxel) is an formulation of that has demonstrated improved efficacy compared with in the treatment metastatic breast cancer. We undertook this trial to determine maximum-tolerated dose (MTD) and single-agent activity NAB-paclitaxel administered on a weekly basis patients stage IV non–small-cell lung cancer (NSCLC). Patients Methods This was open-label, single-arm, phase I/II study. were treated intravenously during 30 minutes without corticosteroid or antihistamine premedications days 1, 8, 15 28-day cycle. Radiologic tumor assessment performed every 8 weeks. Results Dose levels 100 125 mg/m2 tolerated dose-limiting toxicities (DLTs). At 150 MTD exceeded; two three experienced DLT (grade 3 sensory neuropathy febrile neutropenia). The level expanded determined be MTD...

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