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Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Bristol-Myers Squibb
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00142428
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Cetuximab
Phase II

Drug Information available for: Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To assess the progression free survival in patients with unresectable or metastatic hepatocellular carcinoma [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the side effects of cetuximab in this population as well as the response rate, duration of response, and overall survival of patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    Given intravenously once a weekly for 6 weeks. The first dose is larger than the following dose. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
Detailed Description:

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 side effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable or metastatic hepatocellular carcinoma
  • Measurable tumor
  • Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7 x upper limit of normal (ULN).
  • Adequate renal function: serum creatinine < 2.0mg/dl
  • Adequate bone marrow function: absolute neutrophil count (ANC) > 1,000/mm3; platelets > 75,000/mm3.
  • 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 an investigational agent within 30 days
  • Cancer of the Liver Italian Program (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142428

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Bristol-Myers Squibb
Investigators
Principal Investigator: Andrew X. Zhu, MD Massachusetts General Hospital
  More Information

Responsible Party: Massachusetts General Hospital ( Andrew Zhu, MD )
Study ID Numbers: 04-347
Study First Received: August 31, 2005
Last Updated: December 28, 2007
ClinicalTrials.gov Identifier: NCT00142428  
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Hepatocellular carcinoma
cetuximab
Unresectable hepatocellular carcinoma
Metastatic hepatocellular carcinoma

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Cetuximab
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009