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Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00057980
First Posted: April 9, 2003
Last Update Posted: June 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
  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 1 Phase 2

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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Maximum tolerated dose of epirubicin
  • Response rate
  • Survival at 6 months
  • Overall survival

Secondary Outcome Measures:
  • 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

Enrollment: 8
Study Start Date: October 2002
Study Completion Date: February 2007
Primary Completion Date: February 2007 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057980


Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Study Chair: Mary Mulcahy, MD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00057980     History of Changes
Other Study ID Numbers: NU 02I6
NU-02I6
First Submitted: April 7, 2003
First Posted: April 9, 2003
Last Update Posted: June 11, 2012
Last Verified: June 2012

Keywords provided by Northwestern University:
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Celecoxib
Epirubicin
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors