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)
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Urethral Neoplasms; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): cisplatin; gemcitabine hydrochloride; sunitinib malate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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)
Other intervention name(s): Sutent
Intervention MeSH terms: Gemcitabine; Sunitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent urethral cancer; recurrent transitional cell cancer of the renal pelvis and ureter; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; posterior urethral cancer; urethral cancer associated with invasive bladder cancer; transitional cell carcinoma of the bladder; stage IV bladder cancer; recurrent bladder cancer; anterior urethral cancer