A Phase II Multicenter Study of Two Different Dosages of Pemetrexed Given in Combination With Cyclophosphamide as First-Line Treatment in Patients With Locally Advanced or Metastatic Breast Cancer

Abstract

Pemetrexed/cyclophosphamide was evaluated as first-line treatment for patients with locally advanced/metastatic breast cancer. In this randomized phase II study (NCT00190671), therapy consisted of either 600 mg/m² (P600) or 1,800 mg/m² (P1800) pemetrexed, followed by 600 mg/m² cyclophosphamide, every 21 days; 103 females (42 P600; 61 P1800) were enrolled. P600 was discontinued, as response rate (19.1%) was lower than targeted. In the P1800 arm, 20 patients had partial response (32.8%; 95% CI: 21.0–44.6) and 26 (42.6%) had stable disease. Median progression-free survival was 6.3 months (range: 0.3–31.1). P1800 plus cyclophosphamide 600 represents a regimen of reasonable efficacy and acceptable tolerability.

Keywords: :

• Multitargeted antifolate
• Failed standard adjuvant therapy
• Pharmacokinetics
• Breast cancer
• Randomized phase II trial

ACKNOWLEDGMENT

This study was supported by Eli Lilly and Company, Indianapolis, Indiana, USA.