A Pilot Study of Neoadjuvant Dasatinib Followed by Radical Cystectomy for Transitional Cell Carcinoma of the Bladder
OUTLINE: This is a multi-center study.
This is a pilot study designed to determine the safety and feasibility of treatment with
dasatinib 100 mg administered orally once daily for 4 weeks duration prior to radical
cystectomy for patients with muscle-invasive transitional cell carcinoma of the bladder
ineligible for and/or willing to forgo neoadjuvant cisplatin-based combination chemotherapy.
If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours
before planned surgery.
ECOG Performance Status 0-1
Life Expectancy: Not specified
- Absolute Neutrophil Count (ANC) > 1.5 K/mm3
- Platelets > 100 K/mm3
- INR < 1.2
- Total bilirubin < 2.0 X Upper Limit of Normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 X ULN.
- Alanine aminotransferase (ALT ) ≤ 2.5 X ULN
- Serum creatinine < 2 X ULN
- No uncontrolled angina, congestive heart failure or MI within 6 months prior to
registration on study.
- No diagnosed congenital long QT syndrome (a congenital disorder characterized by a
prolongation of the QT interval on ECG and a propensity to ventricular
tachyarrhythmias, which may lead to syncope, cardiac arrest, or sudden death).
- No history of clinically significant ventricular arrhythmias (such as ventricular
tachycardia, ventricular fibrillation, or Torsades de Pointes).
- No prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), obtained within
28 days prior to being registered on study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasibility of treatment with dasatinib prior to radical cystectomy in patients with muscle invasive transitional cell carcinoma of the bladder.
Noah Hahn, M.D.
Hoosier Oncology Group, Inc.
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Virginia Oncology Associates||Newport News, Virginia 23606|
|Indiana University Simon Cancer Center||Indianapolis, Indiana 46202|