CEBOC

Trial Name: Evaluation of the safety of CEdiranib in the prevention of Bowel perforation in platinum-resistant Ovarian Cancer

Chief Investigator: Professor Gordon Jayson

Trial Description: This is a single arm, phase II trial of cediranib 20mg/day with weekly paclitaxel 70mg/m2/week in patients with recurrent platinum-resistant ovarian cancer and clinical and/or radiological features indicating an increased risk of developing subacute bowel obstruction.

Background: In the UK, ovarian cancer is the fourth most common cause of female cancer death and the commonest cause of gynaecological cancer death accounting for 4,000 lives a year in the UK. The principal cause of death in ovarian cancer is malignant bowel obstruction. Because the disease causes multi-site obstruction of the bowel, surgery is seldom possible and there is a critical need to develop new treatments to stop development of bowel obstruction as effectively and safely as possible. CEBOC is the first trial that has been developed specifically to address the management of malignant bowel obstruction. CEBOC aims to take advantage of the additive effects of combining a VEGF inhibitor, cediranib, with an effective chemotherapeutic regimen, weekly paclitaxel. Subsequently, the patient can continue cediranib with the addition of an additional drug, olaparib at the point of progression.

Main Outcomes: The main objective of the trial is to determine the safety of combining cediranib with paclitaxel. Safety will be assessed by monitoring the frequency of two serious adverse events, bowel perforation and fistula. The trial will also summarise the side-effects of the treatments and how well the treatment works in terms of controlling the disease and preventing bowel obstruction.

Patients to be recruited: 30

Status: Live

CTU: Cardiff

Funder: AstraZeneca

Further Information: Study Contact Clare Freestone CEBOC@cardiff.ac.uk