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

Liver Cancer Clinical Trial

— NRR  

Official title:

Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483405
• Other study ID #: LCCC 0421
• Secondary ID: CDR0000550159
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2007
• Last updated: January 20, 2016
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: January 2016
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 CNS metastases (unless CNS metastases stable for > 3 months)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC = 1,500/mm³

• Hemoglobin = 9 g/dL

• Platelet count = 100,000/mm³

• Bilirubin = 3 times ULN

• INR = 1.5

• AST and 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 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Biological:
• cetuximab
250 mg/m2, intravenously, once per week

Drug:
• 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.
• oxaliplatin
130 mg/m2, intravenously on Day 1 of each 21 day cycle

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Response Rate	Radiographic response will be measured every sis weeks while subject is on treamtment. Response will be measured using RECIST criteria.	every 6 weeks	No
Secondary	Number of subjects experiencing adverse events	Adverse events will be assessed using CTCAE critera.	every 3 weeks of treatment	Yes
Secondary	Overall Survival	Overall survival will be calculated from time of enrollment to death or last contact date.	time of enrollment until death	No
Secondary	Time to progression	Time to progression will be calculated from the time of enrollment until confirmed disease progression	Enrollment until confirmed disease progression	No