A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients
- Determine the clinical toxic effects associated with administering sequential
gemcitabine followed by fluorouracil with leucovorin calcium in patients with
refractory or recurrent or metastatic solid tumors or lymphomas.
- Determine achieved steady-state plasma levels of gemcitabine and fluorouracil in these
- Determine any antitumor activity of this regimen in these patients.
- Determine the pharmacodynamics of gemcitabine and fluorouracil in these patients.
OUTLINE: This is a dose-escalation study of fluorouracil and gemcitabine.
During the first course, patients receive gemcitabine IV over 30 minutes once weekly for 2
weeks followed by one week of rest. During subsequent courses, patients receive gemcitabine
as above followed immediately by fluorouracil IV over 24 hours once weekly for 2 weeks.
Patients also receive leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9.
Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of fluorouracil is followed by sequential dose escalation of
gemcitabine. Cohorts of 3-6 patients receive escalating doses of fluorouracil and then
gemcitabine until the maximum tolerated dose (MTD) of the combination is determined. The MTD
is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 108 patients will be accrued for this study.
Primary Purpose: Treatment
Eva Szabo, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|