CEBOC

Evaluation of the safety of cediranib in the prevention of bowel perforation in platinum-resistant ovarian cancer.

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.

Study design

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. CEBOC will recruit 30 women aged 18 years or older with ovarian cancer, which has placed the patient at risk of developing bowel obstruction.

Study aim

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.

Results

Bowel obstruction (blockage)

Safety testing

We planned to treat the patients with weekly paclitaxel, a standard chemotherapy option in this situation. However, we knew that drugs, which block blood vessel formation increase the effectiveness of chemotherapy when given with chemotherapy, yet they can also cause bowel damage if given to patients with bowel obstruction caused by cancer. In CEBOC we therefore wanted to test the safety of adding a drug that blocks blood vessel formation, called cediranib, to weekly paclitaxel.

Effectiveness of paclitaxel