Trial intelligence / Profile preview

IXO + Bevacizumab in Metastatic Colorectal Cancer

NCT00819754Phase 2

Key facts

Status: Terminated
Start: Nov 2003
Primary completion: Feb 2012
Countries: 1
Sponsor: Ottawa Hospital Research Institute
Modality: Monoclonal Antibodies, DNA Intercalators/Alkylators, Irreversible Covalent Inhibitors

Drugs: bevacizumabirinotecancapecitabineoxaliplatin
Conditions: metastatic colorectal cancer (mCRC)

Overview

Phase 2, open-label, single-arm trial of bevacizumab, irinotecan, capecitabine and oxaliplatin in metastatic colorectal cancer (mCRC), sponsored by Ottawa Hospital Research Institute. Primary endpoints: Maximum Tolerated Dose at 3 weeks, Recommended Dose at 3 weeks and 1 more. Started Nov 2003; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

IXO regimen + bevacizumab
Irinotecan, capecitabine, oxaliplatin (IXO) + bevacizumab combination therapy

Who it enrols

Adults with unresectable, advanced/metastatic colorectal adenocarcinoma, ECOG 0-2, no prior chemotherapy for metastatic disease, no prior adjuvant irinotecan/oxaliplatin, no brain metastases, and no Gilbert's disease.

Endpoints

Primary

Maximum Tolerated Dose3 weeks
Recommended Dose3 weeks
Progression-Free Survival3 weeks

Secondary

Objective Response Rate6 weeks
Duration of Response6 weeks
Overall Survivalcontinuous
Qualitative and quantitative toxicitycontinuous

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