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The combination of ifosfamide, paclitaxel, and vinorelbine has been studied as a chemotherapy regimen for advanced non-small-cell lung cancer (NSCLC). This three-drug combination was investigated in phase I-II clinical trials to determine its efficacy, toxicity profile, and appropriate dosing[1]. ## Clinical Studies In a phase I-II trial, researchers aimed to define the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of paclitaxel when combined with ifosfamide and vinorelbine, with filgrastim (G-CSF) support[1]. The study enrolled 56 patients with stage IIIB or IV NSCLC, with 27 patients in the phase I portion and 29 additional patients at the recommended phase II dose[1]. The recommended phase II dose was determined to be paclitaxel 135 mg/m² with ifosfamide 1.2 g/m²/day on days 1-3 and vinorelbine 20 mg/m²/day on days 1-3 with G-CSF support[1]. This regimen was administered on a 21-day cycle. ## Efficacy and Toxicity The overall response rate for this combination was 18%, with a median survival of 6.1 months[1]. At the recommended phase II dose, 6 of 35 patients (17%) achieved a partial response to therapy[1]. The primary dose-limiting toxicity was myelosuppression. Grade IV neutropenia was observed in 19 of 35 patients at the recommended phase II dose, with eight patients experiencing febrile neutropenia[1].
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