Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
OBJECTIVES: * Determine the maximum tolerated dose and recommended phase II dose of UCN-01 and irinotecan in patients with advanced solid tumors, primarily lung, ovarian, and gastrointestinal tumors. * Determine the acute and chronic toxicity profile of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine, preliminarily, the anti-tumor effect of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive UCN-01 IV over 3 hours on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of UCN-01 and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the recommended phase II dose. Patients are followed at 1 month. PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 7-15 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
