Abstract
The objective of this phase I study was to identify the maximum tolerated dose (MTD) and toxicity of a three drug, platinum-free regimen, including gemcitabine, ifosfamide and vinorelbine, in the treatment of patients with advanced non-small cell lung cancer (NSCLC). 33 chemotherapy-naı̈ve patients with histologically confirmed, unresectable NSCLC, received fixed doses of ifosfamide (1500 mg/m 2 days 1–3 with mesna) and vinorelbine (25 mg/m 2 days 3 and 8). The gemcitabine dose was escalated from 500 to 1200 mg/m 2 on days 3 and 8 every third week. The escalation was stopped at dose level 4 (gemcitabine 1200 mg/m 2) since all 3 patients of this cohort showed dose-limiting thrombocytopenia and/or neutropenia at treatment cycle 1. The dose recommended for phase II trials is: gemcitabine 1000 mg/m 2 and vinorelbine 25 mg/m 2 given on days 3 and 8 plus ifosfamide 1500 mg/m 2 on days 1–3. An encouraging response rate of 50% (95% confidence interval (CI): 32–68%) was observed in 32 patients evaluated. Our results show that ifosfamide, vinorelbine and gemcitabine can be safely administered as outpatient chemotherapy for NSCLC. Myelosuppression is the dose-limiting toxicity (DLT) of this regimen with no major subjective side-effects observed.
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