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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Up to six 21 day chemotherapy cycles: Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 \& 8) Sunitinib 37.5mg (po days 2 to 15)
Up to six 21 day chemotherapy cycles: Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 \& 8) Sunitinib 37.5mg (po days 2 to 15)
Up to six 21 day chemotherapy cycles: Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 \& 8) Sunitinib 37.5mg (po days 2 to 15)
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
...and 6 more locations
Progression-free survival
Proportion of patients progression free at 6 months
Time frame: 6 months
Toxicity during and after treatment according to NCI CTCAE v 3.0
Time frame: 1 Year
Tolerability (side effects) and feasibility of use (number of patients requiring dose delays or reduction and/or treatment withdrawal)
Time frame: 1 year
Overall survival
Time frame: 3 years
Progression-free survival (time-to-event)
Time frame: 1 year
Objective (radiological) response rate according to RECIST
Time frame: 1 year
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