A Phase I Study of Docetaxel Plus 5-FU, Cisplatin and Leucovorin in Patients With Advanced Solid Tumors

Trial Information

A Phase I Study of Docetaxel Plus 5-FU, Cisplatin and Leucovorin in Patients With Advanced Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel administered in combination
with cisplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors.
II. Determine the toxicities associated with this combination regimen in this patient
population. III. Evaluate the clinical response to this combination regimen in these
patients.

OUTLINE: This is a dose escalation study of docetaxel and fluorouracil (5-FU). Patients
receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 2, and leucovorin
calcium IV immediately followed by 5-FU IV on days 1-5. Treatment repeats every 3 weeks in
the absence of disease progression. Cohorts of 3-5 patients receive escalating doses of
docetaxel and 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose
limiting toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 2 years.