Abstract
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/m(2) 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 > or = 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.
MeSH terms
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Administration, Oral
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Antimetabolites, Antineoplastic / administration & dosage
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Antimetabolites, Antineoplastic / adverse effects
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Antimetabolites, Antineoplastic / therapeutic use*
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Carcinoma, Transitional Cell / drug therapy*
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Carcinoma, Transitional Cell / mortality
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Carcinoma, Transitional Cell / secondary
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Drug Administration Schedule
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Folic Acid / administration & dosage
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Folic Acid / therapeutic use
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Glutamates / administration & dosage
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Glutamates / adverse effects
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Glutamates / therapeutic use*
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Guanine / administration & dosage
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Guanine / adverse effects
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Guanine / analogs & derivatives*
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Guanine / therapeutic use
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Humans
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Infusions, Intravenous
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Pelvic Neoplasms / drug therapy*
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Pelvic Neoplasms / mortality
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Pelvic Neoplasms / pathology
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Pemetrexed
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Salvage Therapy*
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Treatment Outcome
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Urethral Neoplasms / drug therapy*
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Urethral Neoplasms / mortality
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Urethral Neoplasms / pathology
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Urinary Bladder Neoplasms / drug therapy*
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Urinary Bladder Neoplasms / mortality
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Urinary Bladder Neoplasms / pathology
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Urothelium / pathology*
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Vitamin B 12 / administration & dosage
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Vitamin B 12 / therapeutic use
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Vitamin B Complex / administration & dosage
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Vitamin B Complex / therapeutic use
Substances
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Antimetabolites, Antineoplastic
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Glutamates
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Pemetrexed
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Vitamin B Complex
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Guanine
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Folic Acid
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Vitamin B 12