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Spots Global Cancer Trial Database for Gemcitabine Hydrochloride, Cisplatin, and Sunitinib Malate as First-Line Therapy in Treating Patients With Locally Advanced And/or Metastatic Transitional Cell Carcinoma of the Urothelium (SUCCINCT)

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Trial Identification

Brief Title: Gemcitabine Hydrochloride, Cisplatin, and Sunitinib Malate as First-Line Therapy in Treating Patients With Locally Advanced And/or Metastatic Transitional Cell Carcinoma of the Urothelium (SUCCINCT)

Official 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

Study ID: NCT01089088

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving gemcitabine hydrochloride and cisplatin together with sunitinib malate may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving gemcitabine hydrochloride and cisplatin together with sunitinib malate and to see how well it works as first-line therapy in treating patients with locally advanced and/or metastatic transitional cell carcinoma of the urothelium.

Detailed Description: OBJECTIVES: * To determine the activity, safety, and feasibility of gemcitabine hydrochloride and cisplatin in combination with sunitinib malate as first-line therapy in patients with locally advanced and/or metastatic transitional carcinoma of the urothelium. OUTLINE: This is a multicenter study. Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, cisplatin IV over 3-4 hours on day 1, and oral sunitinib malate once daily on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 6 months and 1 year. Peer Reviewed and Funded or Endorsed by Cancer Research UK

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Bristol Haematology and Oncology Centre, Bristol, Avon, United Kingdom

Castle Hill Hospital, Cottingham, East Yorkshire, United Kingdom

Royal Bournemouth Hospital, Bournemouth, England, United Kingdom

Churchill Hospital, Oxford, Oxfordshire, United Kingdom

Royal Shrewsbury Hospital, Shrewsbury, Shropshire, United Kingdom

The Royal Marsden Hospitals (Surrey), Sutton, Surrey, United Kingdom

St James's University Hospital, Leeds, Yorkshire, United Kingdom

Addenbrooke's Hospital, Cambridge, , United Kingdom

Velindre Hospital, Cardiff, , United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

St Bartholomew's Hospital, London, , United Kingdom

Hammersmith Hospital, London, , United Kingdom

St Mary's Hospital (Paddington), London, , United Kingdom

Charing Cross Hospital, London, , United Kingdom

Christie Hospital, Manchester, , United Kingdom

Southampton General Hospital, Southampton, , United Kingdom

Contact Details

Name: Tom Geldart

Affiliation: Royal Bournemouth Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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