Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

Phase 2 Terminated 23 enrolled Fox Chase Cancer Center

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Timeline

Start: 2006-04-12
Primary completion: 2009-04
Completion: 2013-12-18

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment closed 10/15/2008 based on data about KRAS.”

Publications

Results Dotan E, Meropol NJ, Burtness B, Denlinger CS, Lee J, Mintzer D, Zhu F, Ruth K, Tuttle H, Sylvester J, Cohen SJ. A phase II study of capecitabine, oxaliplatin, and cetuximab with or without bevacizumab as frontline therapy for metastatic colorectal cancer. A Fox Chase extramural research study. J Gastrointest Cancer. 2012 Dec;43(4):562-9. doi: 10.1007/s12029-012-9368-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Comparator	Capecitabine	Small molecule	850 mg/m2	Oral
Comparator	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Comparator	Oxaliplatin	Small molecule	130 mg/m2	Intravenous