Conditions: Transitional Cell Carcinoma of the Bladder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
This pilot study is designed to determine feasibility and safety of treatment with dasatinib administered orally once daily for 4 weeks duration prior to radical cystectomy for urothelial carcinoma of the bladder.

Detailed description:
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

Hematopoietic:

* Absolute Neutrophil Count (ANC) \> 1.5 K/mm3
* Platelets \> 100 K/mm3
* INR \< 1.2

Hepatic:

* Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 X ULN.
* Alanine aminotransferase (ALT ) ≤ 2.5 X ULN

Renal:

* Serum creatinine \< 2 X ULN

Cardiovascular:

* 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.

Arms:
arm 1: Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose

Interventions: intervention 1: Dasatinib intervention 2: Radical Cystectomy
Intervention descriptions: intervention 1: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week) intervention 2: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.

Protocol document: