Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT00020748|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 24, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: epirubicin hydrochloride Drug: irinotecan hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||October 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020748
|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 Comprehensive Cancer Center|