mEOC: Chemotherapy in chemonaive patients with mucinous ovarian cancer

• Research type

  Research Study

• Full title

  mEOC: A multicentre randomised trial comparing oxaliplatin + capecitabine versus carboplatin + paclitaxel in patients with previously untreated mucinous ovarian (mEOC) cancer

• IRAS ID

  537

• Contact name

  Martin Gore

• Sponsor organisation

  University College London

• Eudract number

  2008-000837-23

• ISRCTN Number

  ISRCTN83438782

• Research summary

  Mucinous epithelial ovarian cancer (mEOC) represents 5% of all advanced epithelial ovarian cancers, and so because this is relatively uncommon, no specific randomised trials have been conducted for these patients. It is evident from case-control studies that patients with advanced mEOC do not respond as well to conventional chemotherapy with carboplatin and paclitaxel as patients with other histological subtypes of epithelial ovarian cancer, and this translates into a worse outcome. This may be due to the fact that there are molecular differences between mEOC and other epithelial ovarian cancers. mEOC shares some molecular similarities with mucinous tumours of gastrointestinal origin, so it is thought that the chemotherapy regimen (oxaliplatin capecitabine) that is effective in treating these gastrointestinal mucinous tumours might improve outcomes for patients with mEOC. Oxaliplatin has also been shown to be active in ovarian cancer. The aim of the trial is therefore to determine the true efficacy of chemotherapy with carboplatin and paclitaxel within the context of a randomised trial; and to determine whether a combination regimen of oxaliplatin and capecitabine might provide higher responses and better outcomes. This trial also aims to determine whether the addition of bevacizumab to chemotherapy improves overall survival. Bevacizumab is effective in treating advanced mucinous GI tumours, and is being trialled for effectiveness in ovarian cancer.In this multicentre trial, patients with mEOC will be randomly assigned to receive chemotherapy with carboplatin and paclitaxel ( bevacizumab) or oxaliplatin and capecitabine ( bevacizumab). The primary outcome is overall survival. 332 women with mEOC will be randomised to receive 6 cycles of their assigned chemotherapy every 3 weeks, followed by 12 additional cycles of bevacizumab (if on bevacizumab arms). Patients will be followed up for 5 years, and survival data will be collected ten years after entry to the trial. A recruitment period of 5 years is planned.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  08/H0720/106

• Date of REC Opinion

  29 Oct 2008

• REC opinion

  Further Information Favourable Opinion