A phase I study of paclitaxel, UFT, and leucovorin

This phase I study examines the dose escalation of UFT given in combination with fixed doses of oral leucovorin and weekly doses of paclitaxel in patients with metastatic solid tumor malignancies (excluding colorectal cancer). There are two main objectives for this study. The first is to determine both the maximum tolerated dose and the dose-limiting toxicities of UFT when administered with leucovorin in combination with weekly paclitaxel (1-hour infusions of 80 mg/m² for 4 weeks every 6 weeks). The second is to define the appropriate dose for phase II studies. Both UFT and leucovorin combinations, as well as paclitaxel, are known to be effective as single agents in heavily pretreated patients with a variety of solid tumor malignancies. UFT plus leucovorin provide activity comparable to that of intravenously administered 5-fluorouracil plus leucovorin, and weekly schedules of paclitaxel offer high dose intensity with limited hematologic toxicity. This combination is advantageous in its ease of administration and could be a tolerated outpatient regimen in patients with metastatic solid tumor malignancies.