NCT01089088

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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Cardiff University · Academic / Other
• Sex: All
• Age: 16 Years – 120 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bladder Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Urethral Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	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)
DRUG	gemcitabine hydrochloride	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)
DRUG	sunitinib malate	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)

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-03-18
• Last updated: 2018-10-26

Locations

16 sites across 1 country: United Kingdom