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

Transitional Cell Carcinoma of the Bladder Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma of the Bladder
• Urinary Bladder Neoplasms

• NCT number: NCT00706641
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Completion date: December 2012