Dose Dense MVAC for Muscle Invasive Bladder Cancer
|Muscle Invasive Bladder Cancer High Risk Urothelial Carcinoma of the Upper Urinary Tracts||Drug: single arm dose dense MVAC||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Neoadjuvant Dose Dense MVAC in Muscle Invasive Bladder Cancer and High Risk Urothelial Carcinoma of the Upper Urinary Tract|
- 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. [ Time Frame: Following completion of the 3rd/final cycle of chemotherapy (about week 9) by CT imaging and at time of surgery for pathologic response. ]
- To assess the toxicity profile of dose dense MVAC given in the neoadjuvant setting. [ Time Frame: Ongoing throughout treatment at each MD visit every 14 days. ]
|Study Start Date:||December 2009|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: dose dense MVAC
standard doses of MVAC given every 14 days x 3.
Drug: single arm dose dense MVAC
standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031420
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Elizabeth Plimack, MD||Fox Chase Cancer Center|