Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|