Abstract
This article describes the design and early results of an open-label, nonrandomized phase I/II trial of oral UFT plus leucovorin therapy lit combination with bolus injections of epirubicin and cyclophosphamide in patients with advanced or metastatic breast cancer. This study was designed as a cohort dose-escalation study with the principal aims being to determine dose-limiting toxicity, overall toxicity, maximum tolerated dose, tumor response, and time to disease progression, Currently there are 22 patients randomized in the study. Overall response rate to date is 56% (66% in the locally advanced group). Based on the preliminary data, the dose-limiting toxicity appears to be neutropenia and the optimum dose of UFT for use in a phase II study appears to be 300 mg/m(2).
| Original language | English |
|---|---|
| Pages (from-to) | 47 - 49 |
| Number of pages | 3 |
| Journal | ONCOLOGY (US) |
| Volume | 14 |
| Issue number | 10 |
| Publication status | Published - 2000 |
| Event | Orzel/UFT Investigators Meeting and Consensus Conference - VANCOUVER, Canada Duration: 1 Jan 2000 → … |
