A Phase II Study of Hepatic Arterial Infusion and Intravenous Chemotherapy versus Intravenous Chemotherapy Alone in Patients with Inoperable Liver Metastases from Colorectal Cancer

Full Title

MCT: A Randomized Phase II Study of Panitumumab plus FOLFIRI with or without Hepatic Arterial Infusion as Second-Line Treatment in Patients with Wild Type RAS who have Unresectable Hepatic Metastases from Colorectal Cancer

Purpose

Patients with colorectal cancer that has spread to the liver (“liver metastases”) tend to live longer if the liver tumors can be surgically removed. Giving chemotherapy can shrink some liver metastases and convert them from inoperable to operable. In this study, researchers want to see if giving chemotherapy directly into the liver as well as intravenously (by vein) is safe and more effective than intravenous chemotherapy alone for shrinking liver tumors in patients with inoperable colorectal liver metastases.

Patients will be randomly assigned to one treatment or the other. One group will have hepatic arterial infusion, which delivers chemotherapy directly to the liver through a small metal pump surgically implanted in the abdomen, as well as intravenous chemotherapy. The second group will only have intravenous therapy.

The chemotherapy drugs used in this study are panitumumab plus a drug combination known as FOLFIRI. Since panitumumab only works in patients with a normal version of a gene called RAS, patients in this study must have a normal version of the RAS gene.

Eligibility

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

  • Patients must have inoperable liver metastases from colorectal cancer and have a normal version of the RAS gene.
  • Patients’ cancers must persist despite one regimen of previous chemotherapy that included the drug oxaliplatin.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Andrea Cercek at 646-888-4189.

Protocol

16-1341

Phase

II

Investigator