Phase 2 Trial of Pemetrexed Disodium and Gemcitabine in Advanced Urothelial Cancer (E4802) : A Trial of the Eastern Cooperative Oncology Group

• Published in: Cancer 2008-06, Vol.112 (12), p.2671-2675
• Main Authors: DREICER, Robert, HAILUN LI, COONEY, Matthew M, WILDING, George, ROTH, Bruce J
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease Progression; Female; Glutamates - administration & dosage; Guanine - administration & dosage; Guanine - analogs & derivatives; Humans; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Neutropenia - chemically induced; Pemetrexed; Survival Analysis; Treatment Outcome; Tumors; Tumors of the urinary system; Urinary Bladder Neoplasms - drug therapy; Urinary tract. Prostate gland
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.23503

There is a need to identify active new regimens in patients with advanced urothelial cancer. Pemetrexed and gemcitabine are active agents in advanced urothelial cancer. A phase 2 trial of the combination of these 2 agents was performed in patients with advanced urothelial cancer who were previously untreated for metastatic disease. Forty-six patients with advanced urothelial carcinoma received pemetrexed disodium 500 mg/m2 and gemcitabine 1000 mg/m2 intravenously on Day 1, with gemcitabine repeated on Day 8. Cycles were repeated every 3 weeks for a maximum of 6 cycles. Two patients attained a complete response, and 12 patients attained a partial response for an overall response rate of 31.8% (90% confidence interval, 20.4%-45.2%). The median time to disease progression was 5.8 months, and the median overall survival was 13.4 months. Thirty-three patients (75%) experienced grade>or=3 neutropenia, and 5 patients (11%) had febrile neutropenia. There were 2 therapy-related deaths. The combination of pemetrexed and gemcitabine had moderate antitumor activity in previously untreated patients with advanced urothelial cancer at the expense of significant myelosuppression.