A study looking at trametinib for women with ovarian or peritoneal cancer (LOGS)

Cancer type:

Ovarian cancer

Status:

Open

Phase:

Phase 2/3

This study is comparing trametinib with standard treatment for women who have low grade serous ovarian or peritoneal cancer. Standard treatment is the most common treatment used. This study is for women whose serous Open a glossary item ovarian or peritoneal Open a glossary item cancer has come back after treatment or it is continuing to grow (progressive cancer).

More about this trial

Treatment for low grade serous ovarian or peritoneal cancer that has come back is usually either hormone therapy or chemotherapy. But doctors are always looking at new ways to treat these cancers.

Trametinib is a new treatment and is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In this study doctors want to compare trametinib with one of the standard treatments. They are

  • Letrozole
  • Tamoxifen
  • Paclitaxel
  • Pegylated liposomal doxorubicin
  • Topotecan

The aims of the study are to

  • See whether trametinib works better than standard treatment
  • Compare the side effects of the treatments and see what impact the treatments have on day to day life
  • Learn more about how trametinib works in the body

Who can enter

You may be able to join study if all of the following apply. You

  • Have been diagnosed with low grade serous ovarian or peritoneal cancer
  • Have cancer that can be measured using scans, an X-ray or by the doctor examining you
  • Have had a least 1 course of chemotherapy with platinum drugs Open a glossary item
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are able to swallow tablets or capsules
  • Have satisfactory blood results
  • Are willing to use reliable contraception during the study and for 6 months afterwards if there is any chance that you could become pregnant
  • Are at least 18 years old

If you have the hormone drug letrozole you must be post menopausal and if you are on HRT you must stop this before joining the study.

You cannot join this study if any of these apply. You

  • Have cancer that has spread to your brain or the membranes covering your brain and spinal cord (carcinomatous meningitis)
  • Have cancer that is pressing on your spinal cord causing spinal cord compression Open a glossary item
  • Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
  • Have had all 5 treatments in the standard treatment group
  • Have already had treatment with a drug similar to the one in this trial -  your doctor can confirm thisHave already had treatment with other biological therapies similar to the one used in this study (your doctor can confirm this)
  • Have had chemotherapy in the past 4 weeks (6 weeks if you have had chemotherapy called nitrosourea Open a glossary item or a drug called mitomycin C)
  • Have had major surgery or radiotherapy in the past 4 weeks
  • Have had hormone therapy in the last week
  • Have had an experimental drug in the past month
  • Have any significant side effects from previous anti cancer treatment apart from hair loss
  • Are taking other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
  • Have a problem with your digestive system Open a glossary item that could affect the way your body absorbs medication
  • Have certain heart problems, lung conditions or eye conditions (the study team can advise about this)
  • Are HIV positive and taking anti retroviral medications
  • Have active hepatitis B or hepatitis C
  • Are known to be very sensitive to drugs similar to those being looked at in the study
  • Have any other medical condition or mental health problem that the study team think could affect you taking part in the trial
  • Are pregnant or breastfeeding

Trial design

This is an international phase 2/3 study. The doctors need about 250 people to take part. It is a randomised study. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

In this study there are 2 treatment groups

  • One group of people have standard treatment
  • One group of people have trametinib

If you are in the group having standard treatment your doctor will discuss with you the different treatments and which one would be best. There are 5 options

Letrozole and tamoxifen
These are tablets you take once a day for as long as they are helping you.

Paclitaxel
You have paclitaxel through a drip into a vein once a week for 3 weeks out of 4. It takes about an hour each time. Each 4 weeks makes one cycle of treatment. You have up to 6 cycles of treatment.

Pegylated liposomal doxorubicin
You have pegylated liposomal doxorubicin through a drip into the vein once a week for 4 weeks. It takes about an hour each time. Each 4 weeks makes one cycle of treatment. You have up to 6 cycles of treatment.

Topotecan
You have topotecan through a drip into a vein once a week for 3 weeks out of 4. It takes about 30 minutes each time. Each 4 weeks makes one cycle of treatment. You have up to 6 cycles of treatment.

Trametinib
Trametinib is a tablet. You take it once a day for as long as it is helping you and you are managing any side effects. The study team will give you a diary so you can write down when you take the tablets and any side effects.

If you are having paclitaxel, pegylated liposomal doxorubicin or topotecan and you are doing well you may have more than 6 cycles. The doctors will discuss this with you.

If you are in the group having standard treatment and your cancer continues to grow you will be given the chance to have trametinib. If your cancer continues to grow and you are taking trametinib you will stop taking this drug.

Before starting the study the doctors will ask for a sample of tissue (a biopsy Open a glossary item) to be taken from your cancer. The doctor will use a needle to get the sample and they may use a CT scan or ultrasound scan to help guide them. You have a local anaesthetic at the area where you have the biopsy.  You should be able to go home the same day.

The study team will ask you to complete some questionnaires, before you start treatment, during treatment and then at 3 different times after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling.  They are called quality of life studies.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • Blood tests
  • Physical examination
  • X-ray or CT scan of your chest
  • CT scan or MRI scan of your tummy (abdomen) and the area between your hip bones (pelvis)
  • Heart trace (ECG Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item) or MUGA scan Open a glossary item
  • Eye test
  • Biopsy

You have some of these tests again during the time you have treatment. The study team will explain what tests you have and when.

How often you visit the hospital will depend on what treatment you have. Again the study team will explain this to you.

You may be asked to give some extra blood samples and you may also be asked to have an extra biopsy. These will be used to see if there are any biomarkers Open a glossary item that will help the doctors know who will benefit most from having trametinib or the other standard treatments. You don’t have to have these extra blood samples or biopsy taken if you don’t want to, you can still take part in the study.

When you finish treatment you see the doctors and have a physical examination and blood tests. You may also have a CT or MRI scan of your abdomen or pelvis if your doctor thinks it necessary.

You will be followed up for the next 10 years. You see the doctors

  • Every 3 months for 2 years
  • Every 6 months for 3 years

You will then be called once a year for 5 years.

Side effects

The most common side effects of trametinib are

The most common side effects of paclitaxel are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Diarrhoea
  • Feeling of being sick
  • Sore mouth
  • An allergic reaction to the drug which may cause skin rash and itching, a high temperature (fever), shivering, dizziness, a headache or breathlessness
  • Pain
  • Muscle weakness
  • Numbness, tingling or pain in your arms or legs
  • Hair loss

The most common side effects of pegylated liposomal doxorubicin include

  • Hair loss
  • Feeling or being sick
  • Sore mouth or mouth ulcers
  • Soreness, redness and peeling skin
  • Weakness

The most common side effects of topotecan include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Constipation
  • Diarrhoea
  • Feeling or being sick
  • High temperature (fever)
  • Pain
  • Tiredness
  • Shortness of breath
  • Hair loss

The most common side effects of letrozole include

  • Pain
  • Tiredness
  • Increased sweating
  • Hot flushes

The most common side effects of tamoxifen include

  • A change to your periods
  • Hot flushes
  • Vaginal discharge

We have more information on

Location

Belfast
Bristol
Cambridge
Edinburgh
Glasgow
Leeds
London
Manchester
Sutton
Taunton

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

Professor Charlie Gourley

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
NHS Greater Glasgow and Clyde
University of Glasgow

Other information

This is Cancer Research UK trial number CRUKE/12/028

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10084

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think