Background:
Cancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump. The HAI pump is installed in the artery that goes to the liver; drugs are administered directly to the liver through this pump. But these tumors often return after treatment. Carfilzomib (CFZ) is a drug approved to treat another kind of cancer. Researchers want to find out if this drug may be helpful when administered through the HAI pump directly to the liver for people with colon, adrenal glands, or bile duct cancer that has spread to the liver.
Objective:
To test the safety of carfilzomib (CFZ) delivered via a hepatic artery infusion (HAI) pump directly to the liver in people with cancer in their liver.
Eligibility:
People aged 18 years or older with cancers of the colon, adrenal glands, or bile ducts that spread to the liver and persist after treatment. They must have a functioning hepatic artery infusion (HAI) pump in place from previous treatment of HAI pump therapy.
Design:
Participants will be screened. They will have a physical exam, blood tests, imaging scans, and a test of their heart function. They will also have a test to show how the blood flows through their liver: A radioactive substance will be injected into a vein, and a special camera will take pictures of the blood flow for up to 1 hour.
Participants will receive the study drug for about 6 months. They will visit the clinic once a week. Their HAI pump will be filled with the drug at each visit; the drug will slowly drain from the pump into the liver. Blood tests and imaging scans will be repeated during the study.
Participants will have follow-up visits 1 and 3 months after their last dose of study drug.
An optional liver biopsy (tissue sample) for research purposes may be done before the study drug is given, and again (optional) within 28 days after first receiving the study drug. Individuals may participate in the study even if they do not agree to have the biopsies done.
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Participants must have a histologically or cytologically confirmed by pathology report diagnosis of colorectal cancer (CRC), intrahepatic cholangiocarcinoma (ICC), or adrenocortical carcinoma (ACC).
Participants must have measurable liver-dominant metastatic disease. Note: liver-dominant metastatic disease is defined as >=75% of metastatic disease present in the liver as assessed by the principal investigator.
Extrahepatic disease should be treated with anticancer therapy, if applicable, and should be stable by RECIST criteria for at least 6 weeks prior to study treatment initiation.
Participants must have previously undergone hepatic artery infusion pump therapy and have a functioning hepatic artery infusion pump in place.
Participants with liver metastases amenable to resection.
Participants who received floxuridine within 6 weeks prior to the study treatment initiation.
Participants who received any anticancer therapy within 2 weeks prior to the study treatment initiation.
Participants who received any investigational agents within 4 weeks prior to the study treatment initiation.
Single group
Carfilzomib
DrugVariable doses, continuously administered via Hepatic Artery Infusion Pump (HAIP) for up to 6 cycles
Establish the safety of hepatic artery infusion (HAI) of carfilzomib (CFZ) in participants with liver metastatic disease who were previously treated with HAI pump therapy
The safety of the study therapy will be evaluated by the maximum dosage at which no more than 1 of 6 participants experience DLT during DLT period (Cycle 1) and by reporting the grade and type of toxicity at each dose level
Establish the Overall Response Rate (ORR), defined as complete response (CR) + partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST)
The proportion of participants with partial response or complete response along with a 95% confidence interval (analyzed in a combined fashion, regardless of dose level).
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