Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer (NRR)

UNC Lineberger Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Liver Cancer

Treatments

Drug: oxaliplatin

Biological: cetuximab

Drug: capecitabine

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00483405

LCCC 0421

5K23CA118431-02 (U.S. NIH Grant/Contract)

KL2RR025746 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

Determine the response rate in patients with advanced hepatocellular carcinoma and hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab.

Secondary

Determine the safety of this regimen in these patients.
Determine the overall survival of patients treated with this regimen.
Determine the time to tumor progression in patients treated with this regimen.

OUTLINE: This is an open label, nonrandomized study.

Patients receive oral capecitabine twice daily on days 1-14, cetuximab IV over 60-120 minutes on days 1, 8, and 15, and oxaliplatin IV over 120 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then every 3 months thereafter.

Enrollment

33 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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