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
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Proportion of patients progression free at 6 months
6 months
No
Tom Geldart
Principal Investigator
Royal Bournemouth Hospital
United Kingdom: Medicines and Healthcare Products Regulatory Agency
CDR0000667764
NCT01089088
April 2009
February 2014
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