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A Randomized Phase II Study of Hepatic Arterial Infusion in Combination with Intravenous Chemotherapy, with or without Bevacizumab in Patients with Resected Liver Metastases from Colorectal Cancer
[Protocol 04-086]
- Full Title :
- RANDOMIZED PHASE II STUDY OF HEPATIC ARTERIAL INFUSION WITH FLOXURIDINE & DEXAMETHASONE IN COMBINATION WITH IV SYSTEMIC CHEMOTHERAPY, WITH OR WITHOUT BEVACIZUMAB (A MONOCLONAL ANTIBODY TO VASCULAR ENDOTHELIAL GROWTH FACTOR)IN PATIENTS WITH RESECTED HEPATIC METASTASES FROM COLORECTAL CANCER
- Purpose :
The liver is frequently a site where metastatic colorectal cancer spreads. One way to treat these metastases 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. Patients who receive this treatment also receive the anticancer drugs oxaliplatin, 5-fluorouracil, and leucovorin, given intravenously (by vein).
In this study, investigators want to determine if adding the drug bevacizumab to this combination treatment increases disease-free survival in patients who have had liver metastases surgically removed (resected). 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.
Patients will be randomly assigned to one of two groups: some will receive hepatic arterial infusion and intravenous chemotherapy plus bevacizumab, while others will receive hepatic arterial infusion and intravenous chemotherapy alone.
- 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 colorectal cancer that has metastasized only to the liver and is amenable to surgical resection.
- Patients may have had prior chemotherapy, but at least 3 weeks must have passed since the last treatment. At least 4 weeks must have passed since any major surgery. Patients who have previously received hepatic arterial infusion of floxuridine may not participate.
- Patients may not have had radiation therapy to the liver.
- Patients who are taking or have recently taken blood thinners may not be able to participate.
For more information and to see if you are eligible for this study, please contact Dr. Nancy Kemeny at 212-639-8068.
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