Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020748
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2001-07-11
Brief Title:
Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA051008 | NIH | None | None |
| GUMC-00191 | None | None | None |
| GUMC-072000-001 | None | None | None |
| NCI-G01-1956 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |