Phase I study of paclitaxel on a 3-hour schedule followed by carboplatin in untreated patients with stage IV non-small cell lung cancer

摘要: This study sought to determine the principal toxicities and feasibility of administering paclitaxel as a 3-hour infusion followed by carboplatin without with granulocyte colony-stimulating factor (G-CSF) in chemotherapy-naive patients stage IV non-small cell lung carcinoma (NSCLC), recommend doses for subsequent clinical trials. Twenty-three were treated at ranging from 175 225 mg/m2 targeting area under concentration-time curve (AUC) 7 or 9 mg/mL.min every 3 weeks. AUCs targeted using Calvert formula estimated creatinine clearance surrogate glomerular filtration rate. A high rate intolerable, mutually exclusive toxicities, consisting primarily thrombocytopenia, well neutropenia, nausea vomiting, mucositis, precluded escalation above AUC mg/m2, which approaches maximum tolerated dose (MTD) given single agent on schedule. Moderate severe peripheral neurotoxicity occurred several after multiple courses. Due heterogeneous nature ability administer clinically-relevant both agents combination G-CSF, further G-CSF was not performed. Nine 23 (39%) total 43% 21 assessable had partial responses (PR). The recommended trials are mg/mL.min. combination, significant antitumor activity noted this phase I trial, indicate that evaluations regimen advanced early NSCLC warranted.