Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT00057980|
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : June 11, 2012
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 I/II 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).
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: celecoxib Drug: epirubicin hydrochloride||Phase 1 Phase 2|
- 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 I:Patients 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Official Title:||Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
- Maximum tolerated dose of epirubicin
- Response rate
- Survival at 6 months
- Overall survival
- Toxicity profile
- Serum vascular endothelial growth factor levels in correlation to response
- Cyclooxygenase-2 expression in tumor tissue and nonmalignant liver tissue in correlation to response
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): NCT00057980
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Mary Mulcahy, MD||Robert H. Lurie Cancer Center|