Liver Cancer Clinical Trial
Official title:
Phase I/II Study of Epirubicin and Celecoxib for 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).
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 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.
;
Primary Purpose: Treatment
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