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Title:
Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma | Investigational New Drugs
Description:
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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cancer, phase, patients, google, scholar, pubmed, cas, pemetrexed, carcinoma, clin, oncol, department, article, therapy, urothelial, medicine, trial, oncology, study, advanced, metastatic, secondline, chemotherapy, bladder, memorial, sloankettering, center, treatment, privacy, cookies, content, galsky, access, solid, previously, treated, division, york, usa, publish, research, search, cisplatin, versus, transitional, cell, genitourinary, service, tumor, joan,
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month download article/chapter metastatic transitional-cell carcinoma metastatic urothelial carcinoma adjuvant cisplatin-based chemotherapy chemotherapy-naïve patients warrants advanced urothelial carcinoma transitional cell carcinoma phase ii trial transitional cell cancer phase ii study metastatic bladder cancer privacy choices/manage cookies receiving perioperative chemotherapy phase iii study related subjects full article pdf topoisomerase ii inhibitor urothelial carcinoma national cancer institute advanced cancer patients platinum-based chemotherapy solid tumor oncology prospective randomized trial cisplatin versus cisplatin cisplatin versus methotrexate mtap deficiency creates long-term survival malignant pleural mesothelioma conditions privacy policy folate reduce toxicity european economic area cervical cancers combination accepting optional cookies article investigational vitamin b12 supplementation check access shepherd fa instant access metastatic disease main content log impaired renal function joseph scattergood & dean journal finder publish line chemotherapy svetlana mironov alexia iasonos author correspondence pemetrexed versus docetaxel small ej
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headline:Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma
description:
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.
datePublished:2006-12-05T00:00:00Z
dateModified:2006-12-05T00:00:00Z
pageStart:265
pageEnd:270
sameAs:https://doi.org/10.1007/s10637-006-9020-9
keywords:
Urothelial carcinoma
Metastatic
Chemotherapy
Pemetrexed
Oncology
Pharmacology/Toxicology
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1573-0646
0167-6997
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headline:Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma
description:
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.
datePublished:2006-12-05T00:00:00Z
dateModified:2006-12-05T00:00:00Z
pageStart:265
pageEnd:270
sameAs:https://doi.org/10.1007/s10637-006-9020-9
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Urothelial carcinoma
Metastatic
Chemotherapy
Pemetrexed
Oncology
Pharmacology/Toxicology
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