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A Phase II Study of Hepatic Arterial Infusion with Floxuridine and Dexamethasone in Combination with Intravenous Bevacizumab in Patients with Unresectable Primary Liver Cancer
[Protocol 06-114]
- Full Title :
- A PHASE II STUDY OF HEPATIC ARTERIAL INFUSION WITH FLOXURIDINE AND DEXAMETHASONE IN COMBINATION WITH INTRAVENOUS BEVACIZUMAB (A MONOCLONAL ANTIBODY TO VASCULAR ENDOTHELIAL GROWTH FACTOR-A), IN PATIENTS WITH UNRESECTABLE PRIMARY HEPATIC MALIGNANCY
- Purpose :
The liver is becoming a frequent site for cancer to start. One way to treat these tumors is to administer the drugs floxuridine and dexamethasone directly into the liver, using a pump that delivers the drugs through the hepatic artery. Floxuridine is an anticancer drug, while dexamethasone is an anti-inflammatory drug that helps protect healthy liver tissue from the side effects of floxuridine.
In this study, investigators want to determine if adding the intravenous drug bevacizumab to this combination treatment can help patients with primary liver cancer that cannot be surgically removed. Bevacizumab is an antitumor agent called an angiogenesis inhibitor. Angiogenesis inhibitors are believed to affect tumor cell growth by attacking the blood vessels that supply tumors with nutrition, rather than by attacking cancer cells directly. It is thought that when new blood vessels are unable to form to feed a growing tumor, the tumor may shrink. Bevacizumab is given intravenously to reduce the likelihood of the cancer spreading beyond the liver.
A second purpose of the study is to evaluate a special technique called "dynamic contrast-enhanced MRI" to study how blood vessels in the tumor change while a patient is receiving chemotherapy. The additional information researchers gather from the MRI scans will be compared to the changes in the size of the tumor over time, and may provide another way to monitor the effectiveness of treatment.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of primary liver cancer that cannot be surgically removed and has not spread beyond the liver.
- Patients may not have had major surgery or open biopsy within the 4 weeks before receiving bevacizumab, nor anticipate a need for major surgery while receiving bevacizumab during the study.
- Patients may not have had prior treatment with floxuridine or dexamethasone nor external beam radiation therapy to the liver.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. William Jarnagin at 212-639-7601.
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