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Brief Title: Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
Official Title: A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer
Study ID: NCT00020748
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States
Name: John L. Marshall, MD
Affiliation: Lombardi Comprehensive Cancer Center
Role: STUDY_CHAIR