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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin (70 mg/m2) IV day 1
Sunitinib malate (37.5 mg) oral daily for days 1-14
University of Florida
Gainesville, Florida, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Baylor College of Medicine
Houston, Texas, United States
Pathological Complete Response (pCR) Rate.
number of participants with a pCR
Time frame: 18 months
Safety Profile
Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC
Time frame: 18 months
Objective Response Rate
To determine the objective response rate for patients with measurable disease according to RECIST.
Time frame: 18 months
Progression Free Survival
Time frame: 18 months
Correlate Biomarker Expression
To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.
Time frame: 18 months
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Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
St. Bartholomew's Hospital (Barts)
London, United Kingdom