Ixabepilone v Paclitaxel/Doxorubicin in Advanced Endometrial Cancer v1
Research type
Research Study
Full title
CA163-196: A Phase III Open Label, Randomized, 2 Arm Study Of Ixabepilone Administered Every 21 Days Versus Paclitaxel Or Doxorubicin Administered Every 21 Days in Women with Advanced Endometrial Cancer Who Have Previously Been Treated with Chemotherapy
IRAS ID
22675
Eudract number
2008-007167-16
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
TITLE: A trial looking at chemotherapy drugs Ixabepilone, Paclitaxel and Doxorubicin in women with advanced endometrial cancer (CA163-196).Endometrial cancer, also called womb cancer, is frequently detected early and therefore treatment has a greater chance of success. However, sometimes even with early treatment, endometrial cancer keeps coming back (recurrent) and occasionally will spread to other organs in the body (metastatic). The spread of the cancer to other organs is called advanced endometrial cancer.Patients who have recurrent or metastatic advanced endometrial cancer are often treated with a combination of chemotherapy drugs. If the cancer comes back again after this chemotherapy there is currently no proven treatment but doctors may commonly prescribe paclitaxel or doxorubicin, which have been chosen as the control chemotherapy in this trial. Ixabepilone is chemotherapy drug which works in a similar way to paclitaxel and has already been used in clinical trials in advanced breast cancer. In this trial we aim to compare ixabepilone against control chemotherapy of either paclitaxel or doxorubicin in women with advanced endometrial cancer who have previously been treated with chemotherapy.Patients who meet the entry criteria for the study will first be assessed to see if it is safe for them to take part. Patients who are then enrolled in this study will be treated by trained Oncology teams in specialised NHS clinics. It is planned for 370 patients to be enrolled worldwide with approximately 16 being enrolled the UK.Study therapy will be given every 21 days according to standard clinical practice. Patients will be able to continue receiving their assigned treatment until their cancer gets worse or their doctor decides they should come out of the study.
REC name
West of Scotland REC 1
REC reference
09/S0703/83
Date of REC Opinion
29 Sep 2009
REC opinion
Further Information Favourable Opinion