Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057980
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2003-04-07
Brief Title:
Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase III Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-06
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 Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining celecoxib with epirubicin may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of epirubicin when given together with celecoxib and to see how well it works in treating patients with hepatocellular carcinoma liver cancer
PURPOSE This phase III trial is studying the side effects and best dose of epirubicin when given together with celecoxib and to see how well it works in treating patients with hepatocellular carcinoma liver cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of epirubicin when administered with celecoxib in patients with hepatocellular carcinoma
Determine the response rate in patients treated with this regimen
Determine the 6-month and overall survival of patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
Determine the effects of this regimen on serum levels of vascular endothelial growth factor and correlate these effects with response in these patients
Correlate the expression of cyclooxygenase-2 in tumor tissue and nonmalignant liver tissue with response in patients treated with this regimen
OUTLINE This is a dose-escalation study of epirubicin
Phase IPatients receive epirubicin IV over 20 minutes on day 1 and oral celecoxib twice daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-5 patients receive escalating doses of epirubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 5 patients experience dose-limiting toxicity
Phase II Additional patients are accrued and treated as in phase I at the MTD of epirubicin
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-52 patients 3-15 for phase I and 12-37 for phase II will be accrued for this study
Determine the maximum tolerated dose of epirubicin when administered with celecoxib in patients with hepatocellular carcinoma
Determine the response rate in patients treated with this regimen
Determine the 6-month and overall survival of patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
Determine the effects of this regimen on serum levels of vascular endothelial growth factor and correlate these effects with response in these patients
Correlate the expression of cyclooxygenase-2 in tumor tissue and nonmalignant liver tissue with response in patients treated with this regimen
OUTLINE This is a dose-escalation study of epirubicin
Phase IPatients receive epirubicin IV over 20 minutes on day 1 and oral celecoxib twice daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-5 patients receive escalating doses of epirubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 5 patients experience dose-limiting toxicity
Phase II Additional patients are accrued and treated as in phase I at the MTD of epirubicin
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 3-52 patients 3-15 for phase I and 12-37 for phase II 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 |
|---|---|---|---|
| NU-02I6 | None | None | None |