Intravesicular Abraxane for Treatment-Refractory Bladder Cancer

Summary

Phase I: To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose. To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67. Phase II: To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy). To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.

Timeline

Start

2008-12

Primary completion

2013-03

Completion

2014-02

Drugs

Indications