Conditions: Colorectal Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.

Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.

Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2. arm 2: Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.

Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.

Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.

Interventions: intervention 1: Bevacizumab intervention 2: Capecitabine intervention 3: Levocetirizine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: