This study is being carried out in New York and New Jersey. It will examine whether adding panitumumab(Vectibix) to chemotherapy reduces the risk of the cancer returning in colorectal cancer patients with liver metastases (cancer that has spread to the liver). The authors will also record any adverse events experienced and patient survival time.
The details
Drugs can be given to the patient in a number of different ways including injections into veins or by mouth. Hepatic arterial infusion (HAI) is another way of giving drugs to patients. HAI involves a very thin tube (catheter) being inserted into the blood vessel that carries blood to the liver. Once the catheter is inserted drugs are delivered to the liver through the thin tube. HAI is a useful way of giving chemotherapy (such as floxuridine [FUDR]) to patients with liver tumors.
Panitumumab is an anticancer drug that blocks the epidermal growth factor receptor (EGFR) protein. As EGRF is involved in cancer growth and spread, panitumumab helps slow cancer growth. It is given to patients in combination with standard chemotherapy regimens such as FOLFIRI (5-fluorouracil [Efudex], leucovorin and irinotecan [Camptosar]).
Who are they looking for?
This study will recruit 78 adult patients with colorectal cancer that has spread to the liver. Patients must have undergone surgery that has successfully removed the liver metastases. They must also have blood tests showing acceptable levels of a range of blood cells and other blood markers.
Patients will be excluded from the study if they have a KRAS mutation (abnormal KRAS gene). Patients will also be excluded if they have any existing liver problems or if they have received HAI floxuridine or radiotherapy to the liver.
How will it work
The participants will be divided into two groups and will receive their drug treatment for six 36 day cycles. All patients will receive floxuridine and the steroid dexamethasone (DexPak) by HAI. They will also receive 5-fluorouracil, leucovorin and irinotecan. The first group will receive panitumumab, while the second group will not. The authors will compare patient survival time and the time until cancer returns in both groups.
