drugset / Trial / NCT01722162

Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer

NCT01722162

Phase 2 Completed 47 enrolled Washington University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how giving a drug called levocetirizine to patients with colorectal cancer affects their tumor response to capecitabine and bevacizumab. Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels that feed them. Patients with colorectal cancer can develop a resistance to the effects of bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving bevacizumab, capecitabine, and levocetirizine dihydrochloride together may be an effective treatment for refractory colorectal cancer.

Timeline

Start
2013-04
Primary completion
2015-10
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Levocetirizine Unknown 5 mg Oral
Background Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Background Capecitabine Small molecule 850 mg/m2 Oral

Indications