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)
- Conditions
- Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer
- Registration Number
- NCT01089088
- Lead Sponsor
- Cardiff University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression-free survival 6 months Proportion of patients progression free at 6 months
- Secondary Outcome Measures
Name Time Method Toxicity during and after treatment according to NCI CTCAE v 3.0 1 Year Progression-free survival (time-to-event) 1 year Overall survival 3 years Tolerability (side effects) and feasibility of use (number of patients requiring dose delays or reduction and/or treatment withdrawal) 1 year Objective (radiological) response rate according to RECIST 1 year
Trial Locations
- Locations (16)
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, Shropshire, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
The Royal Marsden Hospitals (Surrey)
🇬🇧Sutton, Surrey, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, Avon, United Kingdom
Churchill Hospital
🇬🇧Oxford, Oxfordshire, 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 Mary's Hospital (Paddington)
🇬🇧London, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, East Yorkshire, United Kingdom
Charing Cross Hospital
🇬🇧London, United Kingdom