Number: 201010736 Principal Investigator: Strasberg, Steven
Title: Drug Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis from Colon Cancer with Concomitant Systemic Oxaliplatin, Fluorouracil and Leucovorin Chemotherapy, and Anti-Angiogenic Therapy
Phase: II Disease Site: Multiple Sites
Participating Site(s):
Main Campus
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The main purpose of this study is to find out if the combination of trans-arterial chemoembolization (TACE) and intravenous (through a needle in your vein) chemotherapy is safe as well as more effective than intravenous chemotherapy alone. Other purposes of this study include finding out more about the side effects of TACE in combination with chemotherapy, if and how the cancer responds to this treatment, the length of time it takes for the disease to worsen and if and how the treatment affects the patient’s quality of life. It is hoped that this study will indicate which treatment option provides the best outcome for patients with this condition.
In this study, TACE refers to the use of microscopic beads called LC beads that are used to deliver chemotherapy directly to the tumor(s) in the liver. The microscopic beads are injected into the liver through the blood vessels that are supplying blood to the tumor. The LC bead is coated with a chemotherapy drug called Irinotecan. Irinotecan has been approved by the United States Food and Drug
Administration (FDA) for the treatment of colorectal cancer that has spread to the liver. The LC bead coated with Irinotecan is considered an investigational product. The use of LC Bead coated with irinotecan in combination with intravenous chemotherapy is also considered investigational.
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