The Pharmacokinetic and Safety Profile of UCN-01 in Combination With Irinotecan in Solid Tumors (Primarily Lung, Ovarian and GI Cancers)
- 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
- 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
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
Primary Purpose: Treatment
Ross C. Donehower, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|