Key information

Recruitment dates:

14 April, 2018 to 31 March, 2020
(Trial recruitment open)

Trial investigator:

Acronym:

CEBOC

Clinical trial locations

Location list

Address:
Winslow Road
Manchester
M20 4BX

Introduction

Bowel obstruction is more common in advanced ovarian cancer where the cancer has spread. The tumour can sometimes grow within your abdomen (tummy) in such a way that it either completely or partially blocks the bowel, causing bowel obstruction.
 This clinical trial is to find the best way to treat women with patinum resistant ovarian cancer who are at risk of developing bowel obstruction and who require further treatment.

About the trial

The main purpose of the trial is to assess the safety of combining two medicines, cediranib with paclitaxel, and how well the treatment works in terms of shrinking the cancer and preventing bowel obstruction.

Three different medicines are being tested as part of the treatment:

 Paclitaxel, a standard chemotherapy drug given as a weekly infusion.

 Cediranib, which is a tablet taken once a day. It is a VEGF-inhibitor.  VEGF is ‘vascular endothelial growth factor’- a chemical which tells the cancer cells to make blood vessels, so that the cancer cells can get nutrients and grow. Cediranib blocks the signals of VEGF.

Olaparib, which is a tablet taken twice a day and is a type of drug called a PARP inhibitor. PARP is short for Poly (ADP-ribose) polymerase. It is a protein that helps damaged cells to repair themselves. Olaparib stops PARP working. Cancer cells with an error in the BRCA gene rely on PARP to keep their DNA healthy. Recent trials have shown that the addition of cediranib to olaparib increases the effectiveness of olaparib even when a genetic mistake in BRCA is not present. Those treated with Olaparib will have their genes tested for the BRCA genetic error by a blood test.

Everyone who takes part in the trial will first receive paclitaxel chemotherapy treatment once a week and bowel symptoms will be assessed and if they improve this will continue with cediranib or cediranib on its own. However, if the cancer worsens during treatment an assessment is made for suitability for treatment with olaparib and the treatment will then be cediranib and olaparib.

Who can take part?

This is a trial for women that have progressive, platinum-resistant or refractory, high-grade ovarian, fallopian tube or primary peritoneal cancer with high risk of bowel obstruction.

That means that you have ovarian cancer that has spread to your tummy (abdomen) and doctors think that you are at risk of bowel obstruction. You also have to have at least 1 area of cancer that can be seen and measured on a scan and that doctors think that the chemotherapy drug paclitaxel is a suitable treatment for you.

 

You are not eligible to join the trial if you are going to have avastin (bevacizumab) maintenance treatment.

There will also be other criteria that your oncologist/clinical trial doctor will explain to you.

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