Phase II study of low-dose infusional 5-fluorouracil and paclitaxel (Taxol) given every 2 weeks in metastatic breast cancer.

Twenty-one patients with recurrent or metastatic breast cancer were treated with paclitaxel (Taxol) as a 1-hour infusion on day 1 only of a 14-day cycle. This treatment was followed by 5-fluorouracil (5-FU) via a portable home pump, through a central venous catheter at 350 mg/m2 per day over 24 hours for a total of 96 hours, on days 1 to 5 and again on days 8 to 12. Based on reported phase I trials in other organ system cancers, the first 5 patients were treated with paclitaxel at 150 mg/m2 every 2 weeks, but this was associated with excessive toxicity.