Conditions: Transitional Cell Carcinoma of the Bladder
Keywords: TCC
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.

Detailed description:
OUTLINE: This is a multi-center study.

* Gemcitabine ( 1000 mg/m2) IV days 1 and 8
* Cisplatin (70 mg/m2) IV day 1 and
* Sunitinib malate (37.5 mg) oral daily for days 1-14

The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

ECOG performance status 0 or 1

Hematopoietic:

* Absolute Neutrophil Count (ANC) \> 1.5 K/mm3 \[(IS): 1.5 x 109/L\]
* Platelets \> 100 K/mm3 \[(IS): 100 x 109/L\]
* Hemoglobin (Hgb) \> 9.0 g/dL \[(IS): 90 g/L\]

Hepatic:

* Total bilirubin \< 1.5 x Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 x ULN
* Alanine aminotransferase (ALT) ≤ 2.5 x ULN

Renal:

* Calculated creatinine clearance of \> 60 cc/min

Cardiovascular:

* No uncontrolled angina, congestive heart failure or myocardial infarction or coronary/peripheral artery bypass graft within 6 months prior to registration for protocol therapy.

Arms:
arm 1: Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy

Interventions: intervention 1: Gemcitabine intervention 2: Cisplatin intervention 3: Sunitinib Malate intervention 4: Radical Cystectomy
Intervention descriptions: intervention 1: Gemcitabine ( 1000 mg/m2) IV days 1 and 8 intervention 2: Cisplatin (70 mg/m2) IV day 1 intervention 3: Sunitinib malate (37.5 mg) oral daily for days 1-14 intervention 4: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

Protocol document: