Phase II Trial of Neoadjuvant Dose Dense MVAC in Muscle Invasive Bladder Cancer and High Risk Urothelial Carcinoma of the Upper Urinary Tract
Primary Objective To assess the rate of complete response (pT0) at cystectomy or
ureterectomy following preoperative dose dense MVAC (DD-MVAC) in patients with muscle
invasive urothelial carcinoma of the bladder or high grade upper tract urothelial carcinoma.
Secondary Objectives To assess the toxicity profile of DD-MVAC when given in the neoadjuvant
setting: To define the number of patients who complete all three cycles of treatment without
dose reduction, and to compare incidence of toxicity to the historical standard described by
Grossman et al. To assess the 5 year overall and relapse free survival in patients who
receive neoadjuvant DD-MVAC. To compare complete response rates between the following
subgroups of study patients: Among bladder patients: Clinical N0 versus N1 (Appendix B)
Among bladder patients: T2 stage without high risk features versus T2 with high risk
features plus those with > T2 stage.
Three 14 day cycles of:
Methotrexate 30 mg/m2 IV push or infusion over 2-3 minutes. Day 1
Vinblastine 3 mg/m2 Slow IV push or infusion over Day 1
Doxorubicin 30 mg/m2 Slow IV push or infusion over 15 minutes Day 1
Cisplatin 70 mg/m2 IV infusion over 4 hours Note: May divide dose over two sequential days
(35 mg/m2/d x 2 days) if creatinine clearance 50-59 mL/min Day 1* (or divided over Day 1
and Day 2)
Pegfilgrastim 6 mg SQ 24-48 hours after completion of chemotherapy.
Followed in 4-8 weeks by radical cystectomy/ureterectomy.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the rate of complete response at cystectomy or ureterectomy following preoperative dose dense MVAC in patients with muscle invasive urothelial carcinoma of the bladder or high risk upper tract urothelial carcinoma.
Following completion of the 3rd/final cycle of chemotherapy (about week 9) by CT imaging and at time of surgery for pathologic response.
Elizabeth Plimack, MD
Fox Chase Cancer Center
United States: Institutional Review Board
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Thomas Jefferson University Hospital||Philadelphia, Pennsylvania 19131|