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

  • Phase II Studies
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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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Authors and Affiliations

  1. Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center; and Department of Medicine, Joan and Sanford Weill Medical College of Cornell University, 1275 York Ave, New York, NY, 10021, USA

    Matthew D. Galsky, Joseph Scattergood & Dean F. Bajorin

  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 Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY, 10021, USA

    Svetlana Mironov

  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 Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY, 10021, USA

    Alexia Iasonos

  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 Medicine, Joan and Sanford Weill Medical College of Cornell University, New York, NY, 10021, USA

    Mary G. Boyle

Authors
  1. Matthew D. Galsky
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  2. Svetlana Mironov
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  3. Alexia Iasonos
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  4. Joseph Scattergood
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  5. Mary G. Boyle
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  6. Dean F. Bajorin
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Correspondence to Matthew D. Galsky.

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Galsky, M.D., Mironov, S., Iasonos, A. et al. Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma. Invest New Drugs 25, 265–270 (2007). https://doi.org/10.1007/s10637-006-9020-9

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  • DOI: https://doi.org/10.1007/s10637-006-9020-9

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