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Journal of Oncology
Volume 2010 (2010), Article ID 785934, 7 pages
http://dx.doi.org/10.1155/2010/785934
Clinical Study

Phase II Study of Biweekly Pemetrexed Plus Irinotecan as Second-Line Therapy for Metastatic Colorectal Cancer

1Service d'Oncologie, Hôpital Saint-Antoine, 184 rue du Faubourg Saint-Antoine, 75012 Paris, France
2Groupe Hospitalier Pitié Salpétrière, Service d'Hépato-Gastroentérologie, Paris, France
3Centre Paul Papin, Angers, France
4Hôpital Claude-Huriez, Lille, France
5Hôpital Foch, Suresnes, France
6Centre Hospitalier Intercommunal Le Raincy-Montfermeil, Montfermeil, France
7Eli Lilly, France

Received 29 July 2009; Accepted 8 February 2010

Academic Editor: Stefano Cascinu

Copyright © 2010 C. Louvet et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. This open-label, single-arm, two-stage, Phase II study investigated the efficacy and safety of bi-weekly pemetrexed combined with irinotecan, in patients with metastatic colorectal cancer (mCRC), after first-line chemotherapy using FOLFOX regimen. Patients and methods. Patients received pemetrexed 400  as a 10-minute intravenous infusion (with vitamin supplementation) followed by irinotecan 180  as a 90-minute infusion on day 1 of a 14-day cycle, for a maximum of 12 cycles. The primary endpoint was response rate (RR; 5%, 20%, , power = 90%). Secondary endpoints were duration of response, progression-free survival (PFS), overall survival (OS), and toxicities. Results. Partial response was observed in six out of 44 patients enrolled in the study (RR = 13.6%). The median PFS and OS were 4.0 and 13.9 months, respectively. The most common grade 3-4 toxicities were fatigue: 20.5% of patients, neutropenia: 18.6%, diarrhea: 13.6%, elevated transaminases: 9.5%, anemia: 9.3%, and vomiting: 6.8%. Conclusion. Pemetrexed plus irinotecan administered every two weeks is an active and well-tolerated regimen in mCRC patients pretreated with FOLFOX regimen. However, this regimen does not seem to provide clinically relevant advantage over historical data of a classical FOLFIRI regimen.