Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

Phase 2 Terminated 14 enrolled National Cancer Institute (NCI)

NaSingle-groupOpen-labelTreatment

Summary

Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well vorinostat works in treating patients with locally recurrent or metastatic cancer of the urothelium.

Timeline

Start: 2006-06
Primary completion: 2010-12
Completion: 2010-12

Outcome

Missed primary endpoint

Stopped: “Trial stopped early for futility”

paper Accrual was terminated in the first stage as no responses were observed. PMID 33409898 ↗

Publications

Quinn DI, Tsao-Wei DD, Twardowski P, Aparicio AM, Frankel P, Chatta G, Wright JJ, Groshen SG, Khoo S, Lenz HJ, Lara PN, Gandara DR, Newman E. Phase II study of the histone deacetylase inhibitor vorinostat (Suberoylanilide Hydroxamic Acid; SAHA) in recurrent or metastatic transitional cell carcinoma of the urothelium - an NCI-CTEP sponsored: California Cancer Consortium trial, NCI 6879. Invest New Drugs. 2021 Jun;39(3):812-820. doi: 10.1007/s10637-020-01038-6. Epub 2021 Jan 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vorinostat	Small molecule	200 mg	Oral