A Phase II Study of Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
The first step in this study is to examine the tumor biopsy (previously collected) and
determine whether or not it is epidermal growth factor receptor (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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the progression free survival in patients with unresectable or metastatic hepatocellular carcinoma
Andrew X. Zhu, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|