At a glance
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A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder
In Brief
A Phase 2 clinical trial evaluating Docetaxel and Oxaliplatin for Metastatic Transitional Cell Cancer of the Urothelial Tract. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.
Study Details
Timeline
Interventions
Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.
Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m\^2