Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma
This study has been completed.
Sponsor:
Northwestern University
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00057980
First received: April 7, 2003
Last updated: June 7, 2012
Last verified: June 2012
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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 [ 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 ]
| 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) |
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
Northwestern University
Investigators
| Study Chair: | Mary Mulcahy, MD | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00057980 History of Changes |
| Other Study ID Numbers: | NU 02I6, NU-02I6 |
| Study First Received: | April 7, 2003 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Federal Government |
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 Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma Epirubicin Celecoxib Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions 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 Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013