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Phase II Study of Capecitabine, Oxaliplatin, and Erlotinib in Previously Treated Patients With Metastastic Colorectal Cancer

Jeffrey A. Meyerhardt, Andrew X. Zhu, Peter C. Enzinger, David P. Ryan, Jeffrey W. Clark, Matthew H. Kulke, Craig C. Earle, Michele Vincitore, Ann Michelini, Susan Sheehan, Charles S. Fuchs

From the Dana-Farber Cancer Institute; and the Massachusetts General Hospital, Boston, MA.

Address reprint requests to Jeffrey A. Meyerhardt, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; e-mail: jmeyerhardt{at}partners.org

PURPOSE: To investigate the combination of erlotinib, capecitabine, and oxaliplatin in patients who were previously treated for metastatic colorectal cancer.

PATIENTS AND METHODS: Patients were eligible if they had metastatic colorectal cancer that progressed, were intolerant to first-line chemotherapy, or had disease recurrence within 1 year of adjuvant therapy for early-stage disease. Each 21-day cycle consisted of daily oral erlotinib at 150 mg, oral capecitabine at 1,000 mg/m² (reduced to 750 mg/m² after the first 13 patients) twice a day on days 1 to 14, and intravenous oxaliplatin at 130 mg/m² on day 1.

RESULTS: Thirty-two patients were enrolled onto this phase II study. By intention-to-treat analyses, eight patients (25%) experienced a partial response and 14 patients (44%) had stable disease for at least 12 weeks. The median progression-free survival was 5.4 months and the median overall survival was 14.7 months. These results were essentially unchanged when limited to the cohort of patients (78%) who received prior irinotecan for metastatic colorectal cancer. Most common grade 3 to 4 toxicities included diarrhea (38%), nausea/emesis (19%), fatigue (16%), dehydration (16%), and dermatitis (13%); grade 3 or 4 toxicities were reduced with a lower starting dose of capecitabine.

CONCLUSION: The combination of capecitabine, oxaliplatin, and erlotinib seems to have promising activity against metastatic colorectal cancer in patients who received prior chemotherapy, with a relatively higher response rate and progression-free survival compared with previous reports of either infusional FU, leucovorin, and oxaliplatin or capecitabine and oxaliplatin in similar patient populations.

Supported by Sanofi-Synthelabo (now Sanofi-Aventis), Roche Labs Inc, and Genentech.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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