At a glance
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An Open Label Study to Assess the Resection Rate of Liver Metastases Following Neoadjuvant Therapy With Avastin in Combination With Oxaliplatin and Capecitabine (XELOX) in Patients With Metastatic Colorectal Cancer With Unresectable Liver Metastasis
In Brief
A Phase 2 clinical trial evaluating bevacizumab [Avastin], capecitabine [Xeloda], and 1 other intervention for Colorectal Cancer. Completed, enrolled 45 participants across 6 sites.
Detailed Summary
This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
5mg/kg iv on day 1 of each 2 week cycle.
1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle
85mg/m2 iv on day 1 of each 2 week cycle