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FOLFOX6, Bevacizumab and Cetuximab in Advanced Colorectal Cancer
NCT00100841Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2004
- Primary completion
- Jul 2011
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Monoclonal Antibodies
- Drugs
- KL-140bevacizumab
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of KL-140 and bevacizumab in colorectal cancer (CRC), sponsored by National Cancer Institute. Primary endpoints: Severe Adverse Event Rate, Progression Free Survival Rate and 1 more. Started Nov 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (combination chemotherapy)
FOLFOX6 + Bevacizumab + Cetuximab
03
Who it enrols
Patients with histologically confirmed stage IV or recurrent adenocarcinoma of the colon or rectum, chemotherapy naïve, ECOG 0-1, and adequate organ function. Excludes prior bevacizumab or cetuximab, brain metastases, and significant cardiovascular disease.
04
Endpoints
Primary
Severe Adverse Event Rate
Progression Free Survival Rate
Objective Response Rate
Secondary
Overall Survival
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