SUCCINCT Trial v1.0

• Research type

  Research Study

• Full title

  A Phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advanced transitional carcinoma of the urothelium.

• IRAS ID

  6392

• Contact name

  Jo Seal

• Sponsor organisation

  Cardiff University

• Eudract number

  2007-007591-42

• ISRCTN Number

  54607216

• Research summary

  The prognosis for patients with advanced urothelial cancer (predominantly bladder cancer) is poor. Approximately 4,700 patients in the UK die each year from the disease. Approximately 50% of patients who are fit enough to undergo cisplatin based chemotherapy will respond to treatment. Median progression-free survival (PFS) for such patients is approximately 8 months and median overall survival 14 months. Despite an increase in our understanding of the molecular basis of cancer over the last 10 years, there have been few clinical studies which specifically target advanced urothelial cancer.Sunitinib (Sutent©) is an oral drug that slows down tumour growth and prevents the formation of new blood vessels associated with cancer growth. Clinical trial data has recently demonstrated sunitinib to be highly active in some cancers, including advanced kidney cancer and rare types of stomach cancer. Early phase clinical trial data confirms that sunitinib is active in urothelial cancer. Additional data also demonstrates that sunitinib can be safely combined with standard cisplatin based chemotherapy.This trial aims to assess whether the addition of sunitinib to standard cisplatin / gemcitibine (CG) cancer chemotherapy improves outcome for participants with advanced urothelial disease.All participants will receive a maximum of six, 21 day cycles of cisplatin and gemcitabine (CG) chemotherapy in combination with sunitinib (SCG). Dose modifications or discontinuation of treatment due to toxicity will be implemented according to specific criteria.If results confirm sufficient activity of the 3-drug sunitinib/cisplatin/gemcitabine (SCG) chemotherapy, the combination treatment will be taken forward into a randomised Phase III setting.

• REC name

  West of Scotland REC 1

• REC reference

  08/S0703/123

• Date of REC Opinion

  14 Jan 2009

• REC opinion

  Further Information Favourable Opinion