LOGS

• Research type

  Research Study

• Full title

  A randomized phase II/III study to assess the efficacy of trametinib (GSK 1120212) in patients with recurrent or progressive low-grade serous ovarian cancer or peritoneal cancer (GOG-0281)

• IRAS ID

  143994

• Contact name

  Charles Gourley

• Contact email

  charlie.gourley@ed.ac.uk

• Sponsor organisation

  NHS Greater Glasgow and Clyde

• Eudract number

  2013-001627-39

• Clinicaltrials.gov Identifier

  NCT02101788

• Duration of Study in the UK

  9 years, 8 months, 1 days

• Research summary

  Summary of Research

  The purpose of this study is to compare the effects of a new drug Trametinib with the standard treatments currently available for treating low grade serous ovarian or peritoneal cancer (either letrozole, tamoxifen, paclitaxel, Pegylated Liposomal Doxorubicin (PLD), or topotecan) to find out whether Trametinib is more effective than the current treatment options.

  Trametinib is a drug that blocks a very important signal that controls the growth of cancer cells. It is thought that this signal is important in a variety of cancers, including low-grade serous ovarian and peritoneal cancers. Trametinib is experimental and has not yet been studied in patients with low-grade serous ovarian or peritoneal cancer.

  In order to study this, a randomised controlled trial is being conducted. In this study half of the patients will be treated with standard chemotherapy or hormone drugs (the choice of this ‘standard’ agent will be advised by at the discretion of the patient's doctor) with the other half of patients entered to the study receiving the new drug Trametinib. A total of 250 patients will be recruited to the study globally.

  In addition to the treatment part of this study, the researchers plan to test samples of patient's tumours and blood. The purpose of this research is to determine whether the presence of certain proteins and genes predict if this drug will be an effective treatment for ovarian or peritoneal cancer. The researchers will also use samples of blood to determine how much of the study drug (trametinib) is present in patients' blood which are receiving trametinib.

  Summary of Results

  Details:
  This trial compared trametinib with standard treatment for women with low grade serous ovarian or peritoneal cancer. It was for women whose cancer had come back or continued to grow despite treatment.

  The trial was open for people to join between 2014 and 2018 in the UK. The team published the results in 2022.

  Trial design
  This trial was for women with low grade serous ovarian or peritoneal cancer. They had all had treatment before. But their cancer had either continued to grow or had come back.

  The women taking part were put into one of two groups at random. Half had trametinib, and half had standard treatment. The doctor looking after them decided which of the 5 standard treatments it would be best to use.

  Results
  A total of 260 women joined this trial – 236 with ovarian cancer and 24 with peritoneal cancer. They were put into a treatment group at random. There were:

  130 people in the trametinib group
  130 people in the standard treatment group

  The research team looked at how long it was before half the people in each group had signs that their cancer started to grow. They call this the median progression free survival.
  They found it was:
  13 months for the trametinib group
  7 months for the standard treatment group

  They looked at how many people were living in July 2019. They found it was:
  79 out of 130 women (61%) who’d had trametinib
  70 out of 130 women (54%) who’d had standard treatment

  Quality of life
  The people taking part filled out quality of life questionnaires. They did this before, during and after treatment.

  The results were similar for those who had trametinib and those who had standard treatment.
  Side effects
  Most people taking part had at least one side effect. Many were mild or didn’t last long. But some people in each group had more severe side effects.

  The most common side effects of trametinib were:

  • rash
  • low red blood cells
  • increased blood pressure
  • diarrhoea
  • feeling sick
  • extreme tiredness (fatigue)
  • The most common side effects of standard treatment included:
  • tummy (abdominal) pain
  • feeling or being sick
  • low red blood cells

  The specific side effects of people in the standard treatment group depends on which treatment people had.

  Conclusion
  The trial team concluded that trametinib was a useful treatment for low grade serous ovarian or peritoneal cancer.

  They suggest it should be the new standard treatment for people whose cancer has come back after initial treatment.

  More detailed information
  There is more information about this research in the link below.

  Please note, this article is not in plain English. It has been written for health care professionals and researchers.
  Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.thelancet.com%252Fjournals%252Flancet%252Farticle%252FPIIS0140-6736&data=05%7C02%7Capprovals%40hra.nhs.uk%7Ccbf84455ad05426a602608de41665682%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639020104980671635%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EEYOVQ3qAzVLLris5M3V1XP8lhCvqBZS6np009Ulf1c%3D&reserved=0(21)02175-9%2Ffulltext/NBTI/BTbCAQ/AQ/3cf558e5-3ea5-4107-9c29-2d59b6a12ba7/1/ENlA8t9IAF

  D Gershenson and others, The Lancet, 2022. Volume 399, Pages 541-551

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  14/ES/1064

• Date of REC Opinion

  16 Oct 2014

• REC opinion

  Further Information Favourable Opinion