Key information

Recruitment dates:

4 September, 2018 to 1 January, 2020
(Trial recruitment open)

Trial investigator:

Dr. Johnathan Krell

Trial website

N/A

 

Acronym:

DICE

Clinical trial locations

Location list

Contact: Dr. Johnathan Krell
Address:
The Hammersmith Hospital
London
Contact: Dr. Susanna Banerjee
Address:
The Royal Marsden Hospital
London and Sutton
Contact: Dr. Sarah Moon
Address:
The Royal Lancaster Infirmary
Lancaster
Contact: Dr. Sarah Moon
Address:
Furness General Hospital
Furness

Introduction

Doctors usually treat ovarian, fallopian tube and primary peritoneal cancers with surgery and chemotherapy. One of the chemotherapy drugs currently used is paclitaxel (also known as Taxol) which is often given with other anti-cancer drugs, like carboplatin. Paclitaxel works by stopping cancer cells dividing into new cells, blocking the growth of the cancer as a result. If the cancer comes back it is possible to have more chemotherapy, but sometimes this treatment stops working because the cancer becomes resistant to it (platinum resistance). Doctors are trying to find new ways to treat women in this situation.

About the trial

An international multi-centre randomised phase II study to assess the efficacy of TAK228 in combination with intravenous weekly paclitaxel compared with weekly paclitaxel alone in women with advanced/recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high grade serous type, and carcinosarcoma).

 This study is looking at using a new drug called TAK228, which comes in capsule form and is being developed for the treatment of cancer. TAK228 has been shown to block two different functions of a protein in the body called mTOR, which controls cell growth. Using TAK228 to interfere with cell growth may slow or stop cancer cells from dividing. Importantly, TAK228 has also been shown to work together with paclitaxel to produce a larger than expected anti-cancer effect in the laboratory and also in smaller clinical trials in participants with various forms of cancer.  As TAK228 is still in development and has not been approved by regulatory authorities, the drug is only available as part of a research study.

The aims of this study are to see whether giving TAK228 and paclitaxel together, to women with ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid or high grade serous subtype, or carcinosarcoma), works better than giving paclitaxel on its own and to learn more about the side effects of adding TAK228 to paclitaxel, and how these compare to paclitaxel on its own.

The study will also look at DNA to try and find ‘biomarkers’. In cancer, a biomarker is anything in the body that can be used to measure or predict the activity of the cancer or the effects of treatment. This will help our understanding of which people may benefit from receiving TAK228 and paclitaxel in future.

Another purpose of this study is to see how differences in the genetic makeup of the cancer may influence the way women respond to or develop side effects from TAK228 when it is given in combination with paclitaxel. This will help us understand in which women these drugs might be most effective and safe to use.

Who can take part?

This is a trial for women with ovarian, fallopian tube or primary peritoneal cancer of clear cell, endometrioid or high grade serous type, or carcinosarcoma that have had chemotherapy previously, but the cancer has grown or come back and is resistant to platinum (carboplatin or cisplatin) chemotherapy.

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