Phase I study of paclitaxel (TaxolQ) and ifosfamide in previously untreated patients with advanced non-small-cell lung cancer*

Summary Background: Paclitaxel (Taxolo) and ifosfamide are among the most active single agents for the treatment of non-smallcell lung cancer. We undertook this phase I dose escalation study to determine the maximum tolerated doses of these drugs which could be administered without growth factors to untreated patients with tumours of this type. Patients and methods: Forty patients with advanced nonsmall-cell lung cancer were treated with a 3-hour infusion of paclitaxel and a 1-hour infusion of ifosfamide every 3 weeks. Groups of 3 patients were entered at escalating dose levels in traditional phase I design. Starting doses were paclitaxel, 100 mg/m2, and ifosfamide 3 g/m2, and all patients received premedication with dexamethasone, diphenhydramine and a 5-HT3 blocker. Dose escalation occurred only after full toxicity assessment for 2 cycles for all patients in the dose level. Results: Dose escalation of paclitaxel continued to 225 mg/m2 without dose-limiting toxicity, but further escalation was not attempted because of the known likelihood of neuro