Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma - Tabular View

Tracking Information

First Received Date ^ICMJE

April 7, 2003

Last Updated Date

January 24, 2009

Start Date ^ICMJE

October 2002

Estimated Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Maximum tolerated dose of epirubicin
Response rate
Survival at 6 months
Overall survival

Change History

Complete list of historical versions of study NCT00057980 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma

Official Title ^ICMJE

Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma

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 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).

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 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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Liver Cancer

Intervention ^ICMJE

Drug: celecoxib
Drug: epirubicin hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00057980

Responsible Party

Study ID Numbers ^ICMJE

CDR0000285669, NU-02I6

Study Sponsor ^ICMJE

Robert H. Lurie Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Mary Mulcahy, MD

Robert H. Lurie Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP