Since cancer is incurable in many patients, palliation of symptoms and qual
ity-of-life issues are important aspects of therapy. Uracil and tegafur (UF
T) plus calcium folinate are the components of the oral agent known as Orze
l, which offers activity comparable to intravenously administered 5-fluorou
racil (5-FU) combined with calcium folinate. Paclitaxel (Taxol), administer
ed intravenously on a weekly schedule, offers high dose intensity and high
response rates with limited hematologic toxicity. It is the aim of this pha
se I study to define the dose-limiting toxicity, possible antitumor activit
y, and appropriate phase II study dose for the combination of UFT plus calc
ium folinate administered orally for 4 weeks phs weekly doses of paclitaxel
The daily dose will be fixed at UFT300 mg/m(2) plus calcium folinate 90 mg
, both divided info three doses per day; paclitaxel will be escalated in ea
ch cohort of patients in 10-mg/m(2) steps, starting with 50 mg/m(2) weekly.
This protocol will fake the success of protracted 5-Fu infusion-here achie
ved orally with UFT plus calcium folinate-in combination with paclitaxel on
e step further by using paclitaxel in a dose-dense, less toxic weekly sched
ule. It may be anticipated that art active outpatient therapy for a variety
of solid tumors will result.