The main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works is treating patients with unresectable of metastatic hepatocellular carcinoma.

Condition	Intervention	Phase
Unresectable hepatocellular carcinoma Metastatic hepatocellular carcinoma Hepatocellular Carcinoma	Drug: Cetuximab	Phase II

Further Study Details: 

Primary Outcomes: To assess the progression free survival in patients with unresectable or metastatic hepatocellular carcinoma.
Secondary Outcomes: To evaluate the side effects of cetuximab in this population as well as the response rate, duration of response and overall survival of patients.
Expected Total Enrollment:  30

• The first step in this study is to examine the tumor biopsy (previously collected) and determine whether or not it is EGFR positive or EGFR negative. Both EGFR positive and EGFR negative patients can participate in this study because at this time it is not known whether having a negative or positive receptor makes a difference in how the study drug works on the tumor. By knowing if the tumor is EGFR positive or negative, we will be able to see if there is a difference in the way the tumor responds to cetuximab.
• Patients will receive cetuximab intravenously once weekly for 6 weeks. Each 6-week period is one cycle of treatment. The first dose of cetuximab is larger than the following doses.
• For the first clinic visit the patient''''s blood pressure, temperature, breathing and heart rate will be taken before, during, at the end, and one-hour after the cetuximab has been administered. For each visit after that, blood pressure, temperature, breathing and heart rate will be taken before and after cetuximab has been administered.
• Before each administration of cetuximab, diphenhydramine will also be administered to decrease the chances of an allergic or hypersensitivity reaction.
• The following tests and procedures will be performed at weeks 1, 3 and 5 during each 6-week cycle of treatments as well as at the end of study treatment: physical exam, vital signs, medical history and blood work. At the end of each 6-week cycle a CT and/or MRI will be performed to measure the tumor size.
• Long-term follow-up will include physical exams and bloodwork every 6 months.
• Patients will remain on cetuximab as long as there is no disease progression or intolerable side effects.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Unresectable or metastatic hepatocellular carcinoma
• Measurable tumor
• Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7x ULN
• Adequate renal function: Serum creatinine < 2.0mg/dl
• Adequate bone marrow function: ANC > 1,000/mm3; platelets > 75,000mm3
• 0-2 prior systemic chemotherapy regimens for hepatocellular carcinoma
• 18 years of age and older
• ECOG performance status of 0-2
• Life expectancy > 12 weeks

Exclusion Criteria:

• Surgery, excluding prior diagnostic biopsy or venous access device placement, within 28 days of study entry
• Uncontrolled serious medical or psychiatric illness
• Irradiation or chemotherapy for disease within 28 days of study entry
• Clinically apparent central nervous system metastases or carcinomatous meningitis
• Received and investigational agents within 30 days
• CLIP score > 3
• Acute hepatitis
• Active or uncontrolled infection
• Significant history of cardiac disease
• Prior cetuximab or other therapy which specifically and directly targets the EGFR pathway
• Prior allergic reaction to chimerized or murine monoclonal antibody therapy

Please refer to this study by ClinicalTrials.gov identifier  NCT00142428

Andrew Zhu, MD      617-724-9420 

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Andrew Zhu, MD,  Principal Investigator,  Massachusetts General Hospital   

Study ID Numbers:  04-347
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142428
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06