Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 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).

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of localized or metastatic hepatocellular carcinoma (HCC) by 1 of the following:

• Biopsy

• Alpha-fetoprotein (AFP) measurement (greater than 400 ng/mL if hepatitis B surface antigen [HBsAg] is negative OR greater than 1,000 ng/mL if HBsAg is positive)

• Not amenable to surgical resection or liver-directed therapy

• Measurable or evaluable disease* NOTE: *Changes in AFP alone are not sufficient

• Child-Pugh score A or B

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 75,000/mm^3

Hepatic

• Bilirubin no greater than 3.0 mg/dL

• AST no greater than 5 times upper limit of normal

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• LVEF greater than 45% by MUGA or echocardiogram

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) except low-dose (81 mg) aspirin

• No known hypersensitivity to aspirin or other NSAIDs

• No contraindication to cyclooxygenase-2 (COX-2) inhibitor therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior therapy for HCC

Trial Contact Information

Trial Lead Organizations/Sponsors

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Mary Mulcahy

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00057980
Information obtained from ClinicalTrials.gov on December 14, 2011

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