Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT01722162
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
  • Capecitabine — DRUG
  • Levocetirizine — DRUG

Study Details

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.

Key Dates

First listed
Nov 6, 2012
Start date
Apr 30, 2013
Status verified
Mar 2017
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
47 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: (start levocetirizine after bevacizumab/capecitabine)
    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.
  • Experimental: Arm B: (start levocetirizine before bevacizumab/capecitabine)
    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.

Primary Outcome Measure

Progression Free Survival (Arm A) [ Time Frame: Until progressive disease (PD) (estimated to be 92 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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