Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Intervention: cetuximab; capecitabine; oxaliplatin
Intervention description: 250 mg/m2, intravenously, once per week; 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.; 130 mg/m2, intravenously on Day 1 of each 21 day cycle
Intervention MeSH terms: Capecitabine; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in
      different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy
      together with a monoclonal antibody may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine
      together with cetuximab works in treating patients with advanced liver cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Meets 1 of the following criteria:

               -  Histologically confirmed hepatocellular carcinoma

               -  Alpha-fetoprotein (AFP) > 400 ng/mL with compatible mass by CT scan or MRI

          -  Metastatic disease OR not a candidate for surgical resection or immediate liver
             transplantation

          -  At least 1 site of measurable disease OR evaluable disease (AFP 2 times upper limit of
             normal (ULN))

          -  No evidence of central nervous system (CNS) metastases (unless CNS metastases stable
             for > 3 months)

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ 3 times ULN

          -  International normalized ratio (INR) ≤ 1.5

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times ULN

          -  Creatinine clearance > 50 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No known hypersensitivity to capecitabine, cetuximab, or oxaliplatin or to other
             murine products

          -  No comorbid condition which is deemed by the investigator to have a life expectancy of
             < 6 months

          -  No New York Heart Association class III-IV coronary artery disease and/or heart
             failure

          -  No variceal bleeding within the past 60 days

          -  No other cancer within the past 5 years except cervical intraepithelial neoplasia,
             nonmelanoma skin cancer, ductal carcinoma in situ, chronic lymphocytic leukemia, or
             treated localized prostate cancer with a normal prostate specific antigen level

          -  No active drug or alcohol abuse

          -  No prior allergic reaction to a therapeutic antibody

          -  No serious, uncontrolled infection

          -  No history of uncontrolled seizures, CNS disorders, or psychiatric disability that, in
             the opinion of the investigator, would preclude study participation or compliance

          -  No other serious uncontrolled medical condition that, in the opinion of the
             investigator, would preclude study participation

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No malabsorption syndrome

          -  No known existing uncontrolled coagulopathy

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior participation in an investigational drug trial

          -  At least 4 weeks since prior major surgery and recovered

          -  At least 4 weeks since prior embolization, resection, or ablation

          -  No prior epidermal growth factor receptor (EGFR)-targeting therapy

          -  No prior systemic chemotherapy or hepatic artery infusion of chemotherapy

          -  No concurrent phenytoin

          -  No concurrent therapeutic warfarin

               -  Low-dose non-therapeutic warfarin to maintain patency of venous access devices
                  allowed