Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma
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).
Drug: epirubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma|
- Maximum tolerated dose of epirubicin [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Survival at 6 months [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity profile [ Designated as safety issue: Yes ]
- Serum vascular endothelial growth factor levels in correlation to response [ Designated as safety issue: No ]
- Cyclooxygenase-2 expression in tumor tissue and nonmalignant liver tissue in correlation to response [ Designated as safety issue: No ]
|Study Start Date:||October 2002|
|Study Completion Date:||February 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|