A trial looking at cediranib for advanced cervical cancer (CIRCCa)

This trial is looking at carboplatin and paclitaxel (Taxol) chemotherapy, with or without a new drug called cediranib (AZD2171) for cervical cancer that has spread.

Doctors often treat cervical cancer that has spread with chemotherapy. Although there is no ‘standard treatment’, doctors often use a combination of carboplatin and paclitaxel.

Researchers think that giving a drug called cediranib alongside carboplatin and paclitaxel may be useful for treating advanced cervical cancer.

Cediranib is a type of biological therapy called an anti angiogenic. Anti angiogenic drugs stop the cancer growing new blood vessels. All cells need a blood supply to grow, so the researchers hope that cediranib will stop the cancer growing.

The aims of this trial are to find out

How well cediranib with carboplatin and paclitaxel works for cervical cancer that has spread
More about the side effects of this combination of drugs
How the treatments affects people’s quality of life

Recruitment

Start 02/06/2010

End 30/06/2012

Phase

Phase 2

Who can enter

You can enter this trial if you have one of the following

Cervical cancer that has come back after radiotherapy and cannot be treated with surgery
Cervical cancer that has come back after surgery
Stage 4b cervical cancer that has spread outside the pelvis since treatment, or had already spread when it was diagnosed

As well as that, you must

Have cancer that cannot be cured with surgery
Have an area of cancer that can be measured on a scan
Be fully active and able to carry out all your normal daily activities, apart from heavy physical work (performance status 0 or 1)
Have satisfactory blood test results
Be prepared to use reliable contraception while you are taking part in the trial and for at least 6 months afterwards
Be at least 18 years old

You cannot enter this trial if you

Have cervical cancer that has spread to the brain
Have cancer that is causing pressure on your spine (spinal cord compression)
Have had chemotherapy before, apart from cisplatin with radiotherapy (chemoradiation)
Are due to have radiotherapy or chemoradiation rather than chemotherapy alone
Have had a major operation or injury in the last month
Have had treatment that inhibits body chemicals (enzymes) called CYP3A4 or 2C8 in the last 2 weeks (your doctor will be able to tell you if this applies to you, but examples include amiodorone, erythromycin, simvastatin and indinovir)
Are still having side effects from treatment you have had (apart from hair loss)
Have had difficulty feeling or moving parts of your body (sensory or motor neuropathy)
Have had an abnormal opening in your pelvis before (a pelvic fistula)
Have a wound, ulcer or fracture that has not healed
Have a history of bleeding or clotting problems
Have heart problems or high blood pressure
Have had a fit (seizure), stroke or brain haemorrhage in the last 6 months
Have bowel or stomach problems
Have had any other cancer in the past, apart from basal cell skin cancer or breast carcinoma in situ which was successfully treated at least 5 years ago
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a randomised trial. The people taking part are put into one of two groups using a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which group you are in. This is called a ‘double blind’ trial.

Everyone taking part has carboplatin and paclitaxel chemotherapy. You have this through a drip into a vein once every 3 weeks. Each 3 week period is one cycle of treatment. You will have 6 cycles over 18 weeks.

The people in group 1 take cediranib tablets. You start take one a day while you are having chemotherapy. But you carry on taking them after you finish chemotherapy, until there are signs that your cancer has started to grow again.

The people in group 2 take dummy (placebo) tablets. As with the cediranib, you take one a day until there are signs that your cancer has started to grow again.

You fill in a questionnaire before each cycle of chemotherapy and every 2 months for a year after that. It will ask you how you have been feeling and about any side effects you have had. It is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

Physical examination
Blood pressure, temperature and heart rate
Blood tests
Urine test
CT scan or MRI scan
Heart trace (ECG)

You go to hospital once every 3 weeks to have chemotherapy. You see the doctors once every 2 months after that. You will have a physical examination, blood tests and urine tests at each appointment.

You have a CT or MRI scan before the 3rd and 5th cycles of chemotherapy, 4 weeks after you finish chemotherapy, and every 2 months for a year after that.