SaPPrOC

• Research type

  Research Study

• Full title

  A randomised placebo-controlled trial of saracatinib (AZD0530) plus weekly paclitaxel in platinum-resistant ovarian, fallopian tube or primary peritoneal cancer.

• IRAS ID

  31106

• Contact name

  Iain McNeish

• Sponsor organisation

  University College London

• Eudract number

  2009-017171-13

• ISRCTN Number

  To be confirmed

• Research summary

  This trial will investigate whether saracatinib significantly improves the effectiveness of weekly paclitaxel chemotherapy in patients with relapsed, platinum-resistant ovarian cancer. Over 6,700 patients are diagnosed with ovarian cancer each year. Over 70% have advanced disease. Advanced patients will receive platinum-based chemotherapy as standard treatment i.e. a chemotherapy drug containing platinum, such as carboplatin. However, 80-90% of patients will relapse, with 20% relapsing within 6 months. Patients that relapse within 6 months of receiving platinum chemotherapy are known as 'platinum-resistant': it is this group of patients that the trial is aimed at. Poor survival rates mean there is a pressing need to identify new treatments. Weekly paclitaxel has shown activity in the treatment of platinum-resistant ovarian cancer. Previous saracatinib trials have shown good response rates for a variety of tumours, including ovarian. This trial will examine the role of combined sacaratinib and weekly paclitaxel, specifically whether the treatment prolongs the time it takes for patients to relapse, 'progression-free survival'. The trial will also examine the side effects, or ??adverse events', and decide whether the treatment should be investigated further. Eligible patients will be randomly assigned to receive either sacaratinib plus weekly paclitaxel, or a placebo plus weekly paclitaxel, to be taken from 1 week prior to the beginning of chemotherapy. All patients will receive four 8-week chemotherapy cycles totalling 32 weeks. For each cycle, paclitaxel will be given once a week for 6 weeks followed by a 2-week break. Saracatinib/placebo will be taken continuously. Before entering the trial patients will receive standard clinical assessments, including physical exam, blood test, and a CT scan of the chest, abdomen and pelvis. These assessments will be repeated at specific times during and after treatment. Additionally patients will fill in questionnaires which assess quality of life.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  10/H1211/26

• Date of REC Opinion

  4 Aug 2010

• REC opinion

  Favourable Opinion