EFC11785 (XRP6258 - Cabazitaxel) - Version 1.0, 14-Dec-2010

• Research type

  Research Study

• Full title

  Randomized, Open Label Multi-Centre Study Comparing Cabazitaxel at 20 mg/m2 and at 25 mg/m2 Every 3 Weeks in Combination with Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen.

• IRAS ID

  71643

• Contact name

  Johann S de Bono

• Sponsor organisation

  sanofi-aventis recherche et developpement

• Eudract number

  2010-022163-35

• ISRCTN Number

  N/A

• Research summary

  Prostate cancer is a major worldwide health problem and is the most frequently diagnosed male malignancy after lung cancer. Worldwide, there were 903,452 new cases and 258,381 deaths due to prostate cancer alone during the year 2008. Prostate cancer is associated with extensive morbidity, as most patients experience significant pain as the result of bone metastases. Patients with advanced disease usually receive treatment with hormonal agents. However, the effect of hormonal manipulation is temporary, and most patients experience disease progression after 18 months of treatment. Although chemotherapy has historically been regarded as modestly effective for the treatment of metastatic castration resistant prostate cancer (MCRPC), recent studies have suggested that this may be changing. Mitoxantrone became the first chemotherapy agent to be approved for the treatment of prostate cancer. Taxotere© in combination with prednisolone was approved in 2004 for the treatment of MCRPC patients and demonstrated a 2.4 month survival benefit compared to mitoxantrone plus prednisolone. Taxotere© (docetaxel) has now been adopted as standard first line therapy for MCRPC. Supportive care, with various non-approved agents with limited activity is used in this setting, palliation being the main goal therapy. Cabazitaxel is a new semisynthetic agent, which acts by stopping cells and particularly cancer cells from dividing and growing. Cell division and growth is out of control in cancer; stopping this should help slow down the growth of cancer. It shows a better antiproliferative activity on laboratory resistant cell lines than Taxotere©. Cabazitaxel plus prednisolone is the first treatment having demonstrated an activity in second line chemotherapy in Hormone Resistant Metastatic Prostate Cancer in patients after Taxotere© containing regimen by increasing the overall survival versus mitoxantrone. The main purpose of this study is to assess if cabazitaxel at 20 mg/m2 is better tolerated and non inferior in terms of efficacy to cabazitaxel 25 mg/m2.

• REC name

  West of Scotland REC 1

• REC reference

  11/AL/0155

• Date of REC Opinion

  20 Apr 2011

• REC opinion

  Further Information Favourable Opinion