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

NCT ID: NCT00483405

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-12-31

Brief 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.

Detailed 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.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm Trial

Single Arm Trial

Group Type: OTHER

cetuximab

Intervention Type: BIOLOGICAL

250 mg/m2, intravenously, once per week

capecitabine

Intervention Type: DRUG

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.

oxaliplatin

Intervention Type: DRUG

130 mg/m2, intravenously on Day 1 of each 21 day cycle

Interventions

cetuximab

250 mg/m2, intravenously, once per week

Intervention Type: BIOLOGICAL

capecitabine

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.

Intervention Type: DRUG

oxaliplatin

130 mg/m2, intravenously on Day 1 of each 21 day cycle

Intervention Type: DRUG

Other Intervention Names

Erbitux; Xeloda; Eloxatin

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bert H. O'Neil, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Michael A. Morse, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

Sanoff HK, Bernard S, Goldberg RM, Morse MA, Garcia R, Woods L, Moore DT, O'Neil BH. Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab for Advanced Hepatocellular Carcinoma. Gastrointest Cancer Res. 2011 May;4(3):78-83.

Reference Type: RESULT

PMID: 22043322 (View on PubMed)

Related Links

http://unclineberger.org

University of North Carolina Lineberger Comprehensive Cancer Center

Other Identifiers

KL2RR025746

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5K23CA118431-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC 0421

Identifier Type: -

Identifier Source: org_study_id