A trial looking at using irinotecan beads for bowel cancer that has spread to the liver - PARAGON II

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer
Colon cancer
Rectal cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at using irinotecan beads to treat bowel cancer that has spread to the liver, before having surgery to remove it.

Doctors often use chemotherapy before surgery to shrink bowel cancer that has spread to the liver. One of the chemotherapy drugs taht doctors often use is called Irinotecan.

To keep growing, cancer cells need a supply of oxygen and food (nutrients). They get these from the blood. If blood vessels around the cancer are blocked then the cancer cannot keep growing and may shrink.

Irinotecan beads are very small beads with irinotecan attached to them. The doctor injects these beads into the blood vessels around the cancer. The treatment combines giving irinotecan straight to the cancer with a way of blocking the blood vessels that supply it.

The aims of this trial are to find out

  • What effect irinotecan beads have on bowel cancer that has spread to the liver
  • How safe irinotecan beads are
  • What the side effects are

Who can enter

You can enter this trial if you

  • Have bowel cancer that has spread to the liver
  • Have surgery planned to remove the cancer in your liver
  • Are well enough to be up and about for at least half the day (performance status 0,1,2)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception if there is a chance either you or your partner could become pregnant
  • Are 18 to 80 years old

You cannot enter this trial if you

  • Have more than 4 areas of cancer in your liver – your doctor can advise
  • Have had irinotecan before
  • Have had chemotherapy in the last 4 weeks
  • Are not able to have irinotecan
  • Have had medication as part of another clinical trial in the last month
  • Have had another cancer, unless you have been treated and there has been no sign of it (complete remission) for the last 10 years – you may join the trial if you have had carcinoma in situ of the cervix or non melanoma skin cancer that has been successfully treated
  • Have an infection
  • Have certain heart problems that are not controlled by medication
  • Have another medical condition that could affect you taking part in this trial

Trial design

This is a phase 2 trial. It will recruit about 40 people in the UK and parts of Europe. Everyone will have treatment with irinotecan beads.

You go to the X-ray department to have the irinotecan beads put in place. First you have a local anaesthetic injection into your groin. The doctor puts a thin tube (a catheter) into the artery in your groin (femoral artery) and threads it up to the hepatic artery that feeds the liver. Once they are sure that the catheter is in the right place, the doctors will inject the irinotecan beads directly into your liver. The doctors will then remove the tube from your groin. The irinotecan beads block blood flow and deliver irinotecan to the cancer.

After 3 to 4 weeks you see the doctor to find out if you are able to have surgery to remove the cancer in your liver. If you are not able to have surgery your doctor will discuss your treatment options.

Hospital visits

You will see the doctor and have some tests before you take part in this trial. These tests include

You will be admitted to hospital the day before having the irinotecan bead treatment and have the following tests

  • Physical examination
  • Blood tests
  • CT scan

If you are well enough you will be able to go home the day after.

After 3 to 4 weeks you will see the doctor and have some tests before surgery. These tests include

  • Physical examination
  • Blood tests
  • CT scan

After surgery you see the doctor at 5 to 10 weeks then at 3, 6, 9 and 12 months.

Side effects

The side effects of irinotecan include

In addition to the side effects of irinotecan, the side effects of having the irinotecan beads put in place include

  • Pain
  • Fever
  • Infection in the liver (abscess)

You can find more about irinotecan on CancerHelp UK.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Graeme Poston

Supported by

Biocompatibles UK Limited

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6339

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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