CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
bevacizumab [Avastin] +2 moredrug
Likely dose
bevacizumab [Avastin] 5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00700570
NCT00700570Phase 2Completed

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

Hoffmann-La Roche·interventional·Posted Jun 18, 2008·Updated Nov 2, 2016

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.0 years ago

Interventions

bevacizumab [Avastin]drug

5mg/kg iv on day 1 of each 2 week cycle.

capecitabine [Xeloda]drug

1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle

oxaliplatindrug

85mg/m2 iv on day 1 of each 2 week cycle