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.
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.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: David J Vaughn; Catherine M Broome; Maha Hussain; John C Gutheil; Avi B Markowitz Journal: J Clin Oncol Date: 2002-02-15 Impact factor: 44.544
Authors: Clet Niyikiza; Sharyn D Baker; David E Seitz; Jackie M Walling; Katrina Nelson; James J Rusthoven; Sally P Stabler; Paolo Paoletti; A Hilary Calvert; Robert H Allen Journal: Mol Cancer Ther Date: 2002-05 Impact factor: 6.261
Authors: D F Bajorin; P M Dodd; M Mazumdar; M Fazzari; J A McCaffrey; H I Scher; H Herr; G Higgins; M G Boyle Journal: J Clin Oncol Date: 1999-10 Impact factor: 44.544
Authors: Atreya Dash; Matthew D Galsky; Andrew J Vickers; Angel M Serio; Theresa M Koppie; Guido Dalbagni; Bernard H Bochner Journal: Cancer Date: 2006-08-01 Impact factor: 6.860
Authors: V Lorusso; C F Pollera; M Antimi; G Luporini; C Gridelli; G L Frassineti; C Oliva; M Pacini; M De Lena Journal: Eur J Cancer Date: 1998-07 Impact factor: 9.162
Authors: S Culine; C Theodore; M De Santis; B Bui; T Demkow; J Lorenz; F Rolland; F-M Delgado; B Longerey; N James Journal: Br J Cancer Date: 2006-05-22 Impact factor: 7.640
Authors: Richard M Bambury; David J Benjamin; Joshua L Chaim; Emily C Zabor; John Sullivan; Ilana R Garcia-Grossman; Ashley M Regazzi; Irina Ostrovnaya; Aryln Apollo; Han Xiao; Martin H Voss; Gopa Iyer; Dean F Bajorin; Jonathan E Rosenberg Journal: Oncologist Date: 2015-04-06
Authors: Guru Sonpavde; Gregory R Pond; Ronan Fougeray; Toni K Choueiri; Angela Q Qu; David J Vaughn; Guenter Niegisch; Peter Albers; Nicholas D James; Yu-Ning Wong; Yoo-Joung Ko; Srikala S Sridhar; Matthew D Galsky; Daniel P Petrylak; Ulka N Vaishampayan; Awais Khan; Nicholas J Vogelzang; Tomasz M Beer; Walter M Stadler; Peter H O'Donnell; Cora N Sternberg; Jonathan E Rosenberg; Joaquim Bellmunt Journal: Eur Urol Date: 2012-11-26 Impact factor: 20.096