ABX209: Phase II Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer.
On the basis of the known single agent activity of paclitaxel in urothelial cancer, the
activity of combination therapy with paclitaxel, carboplatin, and gemcitabine in advanced
urothelial cancer coupled with the results from studies in breast cancer demonstrating
improved clinical efficacy of ABI-007 over paclitaxel with a more favorable toxicity
profile, we propose this phase II trial evaluating the efficacy and safety of the
combination of ABI-007, carboplatin, and gemcitabine in patients with advanced urothelial
Carboplatin and gemcitabine dosing and schedule is based on our previous trial of
paclitaxel, carboplatin, and gemcitabine which showed acceptable toxicity.
Due to the extent of hematologic toxicities expected with this combination and reported with
weekly schedules of ABI-007 based combinations as well as our experience on UMCC protocol
2007.061 which originally utilized a weekly ABI-007 with gemcitabine and carboplatin, we do
not feel continuous weekly dosing will be feasible. Therefore this trial is designed with
ABI-007 on a D1 only schedule every 21 days. The starting dose of ABI-007 will be 220
mg/m2, because of the risk of significant bone marrow suppression, with the option of a dose
escalation in patients who tolerate therapy well after the first cycle to 260 mg/m2 every 21
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical efficacy of ABI-007 based therapy
Maha Hussain, MD
University of Michigan Medical School/Internal Medicine Dept.
United States: Institutional Review Board
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|