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SIR-Spheres with Cetuximab + Irinotecan Therapy

SIR-Spheres, resin microspheres containing pure Beta emitter Yttrium-90, given through femoral catheter over 10 minutes.

SIR-spheres Agent Administration

400 mg/m2 by vein over 2 hours once a week.

Cetuximab infusions will be continued weekly at a dose of 250 mg/m2 unless toxicity necessitates interruptions.

350 mg/m2 (or 300 mg/m2 in patients who are greater or equal to 70 years of age, or have an ECOG PS of 2 or have had prior pelvic and/or abdominal irradiation), by vein over 90 minutes, every three weeks.

Ravi Murthy, MD

The goal of this clinical research study is to find out what effects radioactive particles, SIR-spheres, have when injected into the liver, followed by systemic chemotherapy with a combination of cetuximab and irinotecan compared to those who have systemic therapy alone, in patients with colon cancer that has metastasized to the liver. The safety of this treatment and how well it controls the disease will also be studied.

Yttrium microspheres are designed to treat cancer that has metastasized to the liver by giving radiation directly to the tumor. SIR-spheres are designed to deliver radiation directly to the tumor. This radiation kills the tumor cells.

Cetuximab is a drug that blocks epidermal growth factor receptor (EGFR). EGFR may be involved in certain types of cancer, including non small-cell lung cancer (NSCLC). When EGFR is stimulated, a series of chemical reactions start that result in a tumor being "told" to grow. Cetuximab tries to stop these reactions by blocking EGFR. This may stop tumors from growing.

Irinotecan is designed to block cell growth by blocking an enzyme that repairs DNA, the building blocks of cells.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1of 2 groups. Participants in one group will receive the SIR-spheres with Cetuximab and Irinotecan therapy. Participants in the other group will just have the Cetuximab and Irinotecan therapy without the SIR-spheres. There is an equal chance of being assigned to either group.

If you are found to be eligible to take part in this study, you will have a blood vessel study (given with x-ray dye) performed. This will help researchers look at the arteries leading to your liver and the surrounding areas. You will receive Versed and Fentanyl, sedative drugs to put you to sleep, intravenously (IV--through a needle in a vein) in your arm. A catheter will be placed through your groin artery into the artery leading to your liver. A catheter is a sterile flexible tube that will be placed into a large artery while you are under local anesthesia and IV sedation. Your physician will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. X-ray dye will be injected through the catheter.

If randomly selected to receive the SIR-Spheres with Cetuximab and Irinotecan therapy, a small amount of radioactive albumin injection (a part of a scan test used to measure the supply of blood through the lungs) will be given to your liver. Images will then be taken to learn if too much of this material (radioactive particles) shows up in your lungs and if your liver anatomy is normal. If everything appears normal, the yttrium microspheres will be given slowly through the catheter in 1 dose. If your liver anatomy is abnormal, the yttrium microspheres will be given slowly through the catheter in 2 doses. After you are given the yttrium microspheres, the catheter will be removed, and pressure will be applied to your groin to stop any bleeding. You will then be monitored for 6 hours to check on your well being. You will be given pain medication, if needed (the same sedative drugs used before).

You will be given standard doses of Zantac (ranitidine) to help to protect the stomach during treatment. Chemotherapy with cetuximab and irinotecan will be given on an outpatient basis. A catheter (PICC line, port-a-cath) may be inserted through a vein in your arm or chest to ensure that the chemotherapy is given without interruption. Irinotecan will be given by IV over 90 minutes, once every 3 weeks. Cetuximab will be given once a week. On Day 1 of treatment, you will be given a test dose of cetuximab, to check for any allergic reactions. After that, cetuximab will be given by IV over 2 hours. Before every dose of cetuximab, you will be given a dose of diphenhydramine by IV, to keep from having any allergic reactions. You will also receive medication to prevent nausea, vomiting, or an allergic reaction.

You will have a single-photon emission computerized tomography (SPECT) scan within 1 week after your treatment. A SPECT scan lets your doctor study the function of your internal organs. You will have blood (about 2 tablespoons) drawn every week for the first 2 months and then once a month on an outpatient basis. This is so researchers can check the function of your kidneys and liver. You will also have a routine physical exam and a computerized tomography (CT) scan performed once a month to check the growth of your tumor. Researchers will check to see if your tumor is responding to the study treatment by looking at the imaging on CT scans every 8 weeks.

You may be taken off this study if your disease gets worse, if you experience intolerable side effects, or if there is not enough of the study drug supply to continue treating your disease.

You will be followed-up by telephone for as long as you have cancer.

This is an investigational study. Yttrium microspheres are FDA approved for hepatic arterial therapy and treatment of liver metastases. Sir-Sphere therapy has been approved for treating colorectal cancer with liver metastases. The combination of cetuximab and irinotecan is FDA approved for metastatic colorectal cancer. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Mets to Liver

Phase II Randomized Study of SIR-Spheres, Yttrium Microspheres With Cetuximab Plus Irinotecan for Patients With Advanced Colorectal Cancer Metastases to the Liver

Sirtex Medical

M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for yttrium microspheres