
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the chemotherapy drug methotrexate for people with a change to a gene called MSH2. It is for people who have
Every cell contains DNA. This is the genetic information which controls how cells behave. In cancer cells, the DNA is changed or damaged. Cancers can have different types of changes in the DNA. One of these is when a called MSH2 is not working properly.
Doctors often use chemotherapy to treat cancer. But sometimes the cancer comes back after treatment and spreads elsewhere in the body.
Methotrexate is a chemotherapy drug that is used to treat some types of cancer. We know from research that methotrexate kills cancer cells when the MSH2 gene is not working properly. Researchers want to find out if it will help people with a faulty MSH2 gene who have cancer that has spread.
The aims of this trial are to
You can enter this trial if you
You cannot enter this trial if you
This phase 2 trial will recruit 56 people. Everybody taking part will have methotrexate.
You have methotrexate as an injection into a vein. The treatment only takes a few minutes. You have another injection a week later and then 2 weeks without any treatment. Each 3 week period is called a cycle of treatment. You have up to 6 cycles of treatment. But if the treatment is helping you, your doctor may talk to you about having it for longer.
During the trial, the researchers will take samples of blood, urine and a hair follicle (such as from an eyebrow). And they will get a sample of the tissue taken when you had surgery to remove your cancer or when you had a .
The researchers will use the samples to try to find substances they can measure in the body to help them tell how well the treatment is working. They call these substances . And they will use the blood samples to look at your
. This is to learn more about how genetic changes can lead to cancer and whether certain changes affect how people respond to treatment.
The trial team may also ask your permission to take an extra biopsy during treatment. This is to learn more about what effect the treatment has on the genetic make up of your cancer. If you don’t want to have this extra biopsy, you don’t have to. You can still take part in the trial.
All samples will be stored safely and may be used in the future, but only for research purposes.
You will be asked to fill out a questionnaire before you start treatment, just before the 2nd and 4th cycle of chemotherapy, and every 3 months for a year after you finish treatment. The questionnaire will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.
The trial team will also ask you to fill out a short questionnaire which asks about other members of your family who have had cancer.
People taking part in this trial may also be asked to join extra studies looking at PET scans and MRI scans. Doctors want to find out if these scans can provide more information about bowel cancer with a faulty MSH2 gene.
You may be able to take part in one or both of these studies. Whether or not you are asked to take part will depend on where you are having your treatment and also where in your body the cancer is.
You will see the doctors and have some tests before you start treatment. The tests include
You go to hospital twice in each 3 week cycle of treatment. You have regular blood tests. And after 9 weeks of treatment you have a CT scan to check that your cancer has not got any bigger. If the scan shows the cancer has grown, you will stop having the trial treatment and the doctors will discuss other treatment options with you. If the cancer has stayed the same size or got smaller, you will have the next 3 cycles of treatment and then another CT scan.
After you finish treatment you will see the trial doctors and have a CT scan every 3 months for up to 1 year.
If you do take part in the MRI or PET scan study (or both), you will have extra scans
Having an MRI scan takes about 15 to 30 minutes. If you have PET scans, you have an injection of a small amount of a radioactive drug first. Then you have to wait an hour before having the scan. The scan itself can take up to an hour.
The side effects of methotrexate include
We have more information about the side effects of methotrexate.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor David Cunningham
Institute of Cancer Research (ICR)
The Royal Marsden NHS Foundation Trust
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”