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Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057980
  Purpose

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).


Condition Intervention Phase
Liver Cancer
Drug: celecoxib
Drug: epirubicin hydrochloride
Phase I
Phase II

MedlinePlus related topics:   Cancer    Liver Cancer   

ChemIDplus related topics:   Epirubicin hydrochloride    Epirubicin    Celecoxib    4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Study Start Date:   October 2002
Primary Completion Date:   December 2005 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057980

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University    
      Chicago, Illinois, United States, 60611

Sponsors and Collaborators
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Mary Mulcahy, MD     Robert H. Lurie Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000285669, NU-02I6
First Received:   April 7, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00057980
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced adult primary liver cancer  
localized unresectable adult primary liver cancer  
adult primary hepatocellular carcinoma  

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Celecoxib
Carcinoma, Hepatocellular
Liver neoplasms
Epirubicin
Carcinoma
Liver Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2008




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