Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * Determine the maximum tolerated dose of fluorouracil when given in combination with UCN-01 and leucovorin calcium in patients with metastatic or unresectable solid tumors. * Determine the clinical toxic effects of this regimen in these patients. * Determine the pharmacokinetics of these drugs in these patients. * Correlate, if possible, the pharmacokinetics of these drugs with clinical toxicity in these patients. * Assess the pharmacodynamic effects of these drugs in these patients. * Assess any clinical activity of this regimen in patients with measurable disease. OUTLINE: This is a dose-escalation study of fluorouracil (5-FU). Patients receive leucovorin calcium (CF) IV over 2 hours and 5-FU IV (at the midpoint of CF administration) on day 1, followed by UCN-01 IV over 36-72 hours, on weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose (RPIID) is defined as the dose preceding the MTD. At least 6 additional patients are treated at the RPIID. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 16 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
