Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma

Phase 2 Completed 39 enrolled Dana-Farber Cancer Institute Amgen · collab Beth Israel Deaconess Medical Center · collab Brigham and Women's Hospital · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to test the effectiveness of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in combination with pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial carcinoma.

Timeline

Start: 2008-12
Primary completion: 2013-12
Completion: 2016-09

Publications

Choueiri TK, Jacobus S, Bellmunt J, Qu A, Appleman LJ, Tretter C, Bubley GJ, Stack EC, Signoretti S, Walsh M, Steele G, Hirsch M, Sweeney CJ, Taplin ME, Kibel AS, Krajewski KM, Kantoff PW, Ross RW, Rosenberg JE. Neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin with pegfilgrastim support in muscle-invasive urothelial cancer: pathologic, radiologic, and biomarker correlates. J Clin Oncol. 2014 Jun 20;32(18):1889-94. doi: 10.1200/JCO.2013.52.4785. Epub 2014 May 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	30 unknown	Intravenous
Subject	Methotrexate	Small molecule	30 mg/m2	Intravenous
Subject	Vinblastine	Small molecule	3 mg/m2	Intravenous
Background	Pegfilgrastim	Protein / enzyme biologic	—	Subcutaneous

Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma

Summary

Timeline

Publications

Drugs

Indications