Colorectal Cancer Clinical Trial
Official title:
A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil,
and leucovorin in treating patients with recurrent, refractory, or metastatic solid tumors
or lymphomas.
OBJECTIVES:
- 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
patients.
- 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
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