Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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 |
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 |
Enrollment: | 30 |
Study Start Date: | January 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Andrew X. Zhu, MD | Massachusetts General Hospital |
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 |
Hepatocellular carcinoma cetuximab Unresectable hepatocellular carcinoma Metastatic hepatocellular carcinoma |
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 |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |