Colorectal Cancer Clinical Trial
Official title:
A Randomised, Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer
This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination
with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with
metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5
mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000
mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2
orally twice a day on Days 1-14 of each 3-week cycle) alone.
No notable trends or interactions in laboratory values, electrocardiogram, or vital signs
suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or
capecitabine monotherapy were observed during the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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