At a glance
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A Combined Phase I and Phase II Trial of Intravesical Abraxane, a Biologically Interactive Albumin-bound Paclitaxel, in the Treatment of Refractory Non-muscle Invasive and in T2 Transitional Cell Bladder Cancer
In Brief
A Phase 2 clinical trial evaluating Abraxane for Bladder Cancer. Completed, enrolled 46 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Abraxane is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Intravesically administered, dose escalation, 6 weekly instillations