Trial intelligence / Profile preview

Avastin + XELOX for Resection of Liver Metastases in mCRC

NCT00700570Phase 2

Key facts

Status: Completed
Start: Aug 2008
Primary completion: Nov 2011
Countries: 1
Sponsor: Roche
Modality: Monoclonal Antibodies

Drugs: bevacizumab
Conditions: metastatic colorectal cancer (mCRC)

Overview

Phase 2, open-label, single-arm trial of bevacizumab in metastatic colorectal cancer (mCRC), sponsored by Roche. Primary endpoint: Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases at 10 weeks. Started Aug 2008; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Avastin + XELOX
Avastin + Oxaliplatin + Capecitabine

Who it enrols

Adult patients (<=75 years) with metastatic colorectal cancer and unresectable liver metastases who are chemotherapy-naive for stage IV disease. Patients must have at least one measurable lesion and ECOG status 0-2. Exclusion criteria include prior Avastin exposure, CNS metastases, uncontrolled hypertension, and use of high-dose aspirin.

Endpoints

Primary

Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases10 weeks

Secondary

Percentage of Participants With Disease Progression3 years
Time to Disease Progression3 years
Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.13 years
Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.13 years

Beyond the preview

Go deeper on NCT00700570.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00700570.