Transitional Cell Carcinoma of the Bladder Clinical Trial
Official title:
A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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