Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating patients who have advanced cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: epirubicin hydrochloride
Drug: irinotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer|
|Study Start Date:||August 2000|
|Study Completion Date:||October 2004|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
- 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 toxicity.
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.
|United States, District of Columbia|
|Lombardi Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Study Chair:||John L. Marshall, MD||Lombardi Cancer Research Center|