NCT00683059

Single Agent Abraxane as Second Line Therapy in Bladder Cancer

A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine what effects the drug Abraxane has on bladder cancer.

Detailed description

For those patients with advanced bladder cancer who have progressed on a platinum based regimen, no widely accepted standard second line therapy currently exists. Taxanes including paclitaxel have exhibited clinical activity in this disease and are sometimes given off study. However, toxicities including neurotoxicity and hypersensitivity reactions often limit the use of paclitaxel. ABRAXANE may allow delivery of a greater dose of paclitaxel to those with bladder cancer with an easier method of administration and with less toxicity.

Conditions

• Transitional Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel	total dose (mg) = body surface area in m2 x study dose (mg/m2) to be injected into a vein once every 3 weeks over 18 months.

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-05-23
• Last updated: 2016-10-17

Locations

5 sites across 1 country: Canada