Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma
18 Years
N/A
Both
Liver Cancer
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 |
