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01-06-2007 | Phase II Studies

Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma

Authors: Matthew D. Galsky, Svetlana Mironov, Alexia Iasonos, Joseph Scattergood, Mary G. Boyle, Dean F. Bajorin

Published in: Investigational New Drugs | Issue 3/2007

Summary

Purpose: The purpose of this single-center phase II study was to determine the activity of pemetrexed administered as second-line therapy in patients with advanced urothelial carcinoma. Methods: Patients with advanced urothelial carcinoma that had relapsed after receiving perioperative chemotherapy, or progressed on first-line chemotherapy for metastatic disease, were eligible for enrollment. Patients received pemetrexed 500 mg/m² every 21 days along with folic acid and vitamin B12 supplementation. Results: A total of 13 patients were enrolled. An objective response was achieved in 1/12 evaluable patients for an overall response rate of 8% (90% upper limit 29%). This level of activity did not meet criteria for expansion based on the pre-defined optimal 2-stage Simon design and the trial was concluded. Treatment was generally well tolerated, however, 2/13 patients developed febrile neutropenia. Non-hematologic grade ≥ 3 toxicity was rare. Conclusions: Pemetrexed as second-line therapy in advanced urothelial carcinoma is associated with modest activity. The role of this novel antifolate in chemotherapy-naïve patients warrants further investigation.

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Title: Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma
Authors: Matthew D. Galsky
Svetlana Mironov
Alexia Iasonos
Joseph Scattergood
Mary G. Boyle
Dean F. Bajorin
Publication date: 01-06-2007
Publisher: Kluwer Academic Publishers-Plenum Publishers
Published in: Investigational New Drugs / Issue 3/2007
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI: https://doi.org/10.1007/s10637-006-9020-9

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