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Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma Cancer



Epirubicin and Celecoxib in Treating Patients With Hepatocellular Carcinoma Cancer

For Condition: adult primary hepatocellular carcinoma,localized unresectable adult primary liver cancer,advanced adult primary liver cancer
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Phase I/II trial to study the effectiveness of combining celecoxib with epirubicin in treating patients who have hepatocellular carcinoma (liver cancer).
Details: OBJECTIVES: - Determine the maximum tolerated dose of epirubicin when administered with celecoxib in patients with hepatocellular carcinoma. - Determine the response rate of 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. - 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 of 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MaryMulcahy,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Mary  Mulcahy 312-695-6180


Additional Information:
Study ID Numbers:  CDR0000285669;  NU-02I6
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057980

Other Advanced Adult Primary Liver Cancer Studies:
1. T900607 in Treating Patients With Unresectable Liver Cancer

2. Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

3. Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)

4. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

5. DX-8951f in Treating Patients With Liver Cancer

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