A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer
- Determine the dose-limiting toxicity and maximum tolerated dose of epirubicin and
irinotecan in patients with advanced cancer.
- Determine the objective antitumor responses in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 1 hour followed by epirubicin IV over 5 minutes on days
1 and 8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable
Sequential dose escalation of epirubicin is followed by sequential dose escalation of
irinotecan. Cohorts of 3-6 patients receive escalating doses of epirubicin and irinotecan
until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Primary Purpose: Treatment
John L. Marshall, MD
Lombardi Cancer Research Center
United States: Food and Drug Administration
|Lombardi Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|