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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the pathological complete response rate.
18 months
No
Noah Hahn, M.D.
Study Chair
Hoosier Oncology Group
United States: Institutional Review Board
HOG GU07-123
NCT00859339
March 2009
April 2011
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
University of Florida | Gainesville, Florida 32610-0277 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |