NCT00706641

Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder

A Pilot Study of Neoadjuvant Dasatinib Followed by Radical Cystectomy for Transitional Cell Carcinoma of the Bladder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
DRUG	Dasatinib	Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week)
PROCEDURE	Radical Cystectomy	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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-06-27
• Last updated: 2016-01-15
• Results posted: 2016-01-15

Locations

3 sites across 1 country: United States