A Phase II Study of Hepatic Arterial Infusion and Intravenous Chemotherapy with or without Panitumumab in Patients with Normal KRAS with Resected Liver Metastases from Colorectal Cancer

Protocol
10-137
Full Title
A Randomized Phase II Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients with Wild Type KRAS Who Have Resected Hepatic Metastases From Colorectal Cancer
Phase
II
Purpose

The liver is a common site of metastases from colorectal cancer. It is often possible to remove these tumors surgically; patients may then be treated with chemotherapy to reduce the risk of recurrence.

The chemotherapy being evaluated in this study will be given in two ways. It will be delivered directly to the liver (regional chemotherapy) via a pump that is placed in the abdomen during surgery. The pump is later filled with FUDR (floxuridine), a chemotherapy drug. Another drug called dexamethasone is added to protect healthy liver tissue from the side effects of the chemotherapy.

The second way to give the chemotherapy is through a vein (intravenous chemotherapy). It treats cancer cells that might be anywhere in the body. Irinotecan, 5-fluorouracil (5FU), and leucovorin are the drugs given intravenously in this study (as well as panitumumab for some patients).

Patients in this study will receive chemotherapy through the pump and intravenously. Patients will be randomly assigned to receive only this treatment, or this treatment plus the drug panitumumab. Panitumumab is a drug that may prevent a tumor from growing. It is a monoclonal antibody that attaches to a protein in tumor cell surfaces called the epidermal growth factor receptor. Researchers want to see if adding panitumumab — a drug already used to treat advanced colorectal cancer — to standard chemotherapy extends the time that a patient remains free of cancer after surgery for colorectal metastases in the liver.

Panitumumab is only active in patients whose tumors contain a normal version of a gene called KRAS, which may be associated with tumor growth. For this reason, patients’ tumors must contain normal KRAS to participate in this study.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have had metastases from colorectal cancer that spread to the liver and were removed surgically.
  • Patients tumors must contain a normal form of the KRAS gene.
  • Patients may have had prior chemotherapy, but at least 3 weeks must have passed since the last dose and entry into the study.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Nancy Kemeny at 646-888-4180.

Disease(s)
Colorectal Cancer
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