Phase 2 trial of pemetrexed disodium and gemcitabine in advanced urothelial cancer (E4802) : A trial of the Eastern Cooperative Oncology Group

✍ Scribed by Robert Dreicer; Hailun Li; Matthew M. Cooney; George Wilding; Bruce J. Roth

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 83 KB
• Volume: 112
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.23503

✦ Synopsis

Abstract

BACKGROUND.

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.

METHODS.

Forty‐six patients with advanced urothelial carcinoma received pemetrexed disodium 500 mg/m^2^ and gemcitabine 1000 mg/m^2^ intravenously on Day 1, with gemcitabine repeated on Day 8. Cycles were repeated every 3 weeks for a maximum of 6 cycles.

RESULTS.

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 ≥3 neutropenia, and 5 patients (11%) had febrile neutropenia. There were 2 therapy‐related deaths.

CONCLUSIONS.

The combination of pemetrexed and gemcitabine had moderate antitumor activity in previously untreated patients with advanced urothelial cancer at the expense of significant myelosuppression. Cancer 2008. © 2008 American Cancer Society.