NCT00020748

Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	epirubicin hydrochloride
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2000-08-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2003-01-27
• Last updated: 2011-03-24

Locations

1 site across 1 country: United States