Finding studies
Finding studies
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Lead
Barbara Ann Karmanos Cancer Institute
With
OBJECTIVES: * Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer. * Assess the toxicity of this combination regimen in this patient population. * Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients. OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
