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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of epirubicin

Safety Issue:

Yes

Principal Investigator

Mary Mulcahy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 02I6

NCT ID:

NCT00057980

Start Date:

October 2002

Completion Date:

February 2007

Related Keywords:

  • Liver Cancer
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611