A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors
Status:
Completed
Trial end date:
2001-03-01
Target enrollment:
Participant gender:
Summary
This is a dose escalation study.
During the first period of this study, an initial pharmacological assessment of fluorouracil
administered intravenously along with oral leucovorin calcium is made. Leucovorin calcium is
given orally bid on days 1-3. Fluorouracil is given as a 24 hour infusion on day 2.
After a 2 week rest period and resolution of any toxicities experienced during the first
period of treatment, patients are given an escalating dose of fluorouracil with fixed doses
of leucovorin calcium and ethynyluracil. Ethynyluracil and leucovorin calcium are given bid
orally on days 1-3 of each week. Fluorouracil is given bid orally on day 2 of each week.
Treatment is repeated for three weeks followed by a one week rest period.
3 to 6 patients are enrolled at each dose level. Dose escalation proceeds until the maximum
tolerated dose (MTD) is determined. MTD is defined as the dose preceding that at which 2 or
more patients experience dose limiting toxicity.