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Investigational New Drugs

, Volume 25, Issue 3, pp 265–270 | Cite as

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

  • Matthew D. GalskyEmail author
  • Svetlana Mironov
  • Alexia Iasonos
  • Joseph Scattergood
  • Mary G. Boyle
  • Dean F. Bajorin
Phase II Studies

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.

Keywords

Urothelial carcinoma Metastatic Chemotherapy Pemetrexed 

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Copyright information

© Springer Science+Business Media, LLC 2006

Authors and Affiliations

  • Matthew D. Galsky
    • 1
    Email author
  • Svetlana Mironov
    • 2
  • Alexia Iasonos
    • 3
  • Joseph Scattergood
    • 1
  • Mary G. Boyle
    • 4
  • Dean F. Bajorin
    • 1
  1. 1.Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center; and Department of MedicineJoan and Sanford Weill Medical College of Cornell UniversityNew YorkUSA
  2. 2.Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Department of Radiology, Memorial Sloan-Kettering Cancer Center; and Department of MedicineJoan and Sanford Weill Medical College of Cornell UniversityNew YorkUSA
  3. 3.Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, The Division of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center; and Department of MedicineJoan and Sanford Weill Medical College of Cornell UniversityNew YorkUSA
  4. 4.Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Department of Nursing, Memorial Sloan-Kettering Cancer Center; and Department of MedicineJoan and Sanford Weill Medical College of Cornell UniversityNew YorkUSA

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