Status:
COMPLETED
Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Neoplasm Metastasis
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal grow...
Eligibility Criteria
Inclusion
- First-line mCRC
- EGFR positive
- Bi-dimensional measurable index lesion
Exclusion
- Previous exposure to EGFR-targeting therapy
- Previous oxaliplatin-based therapy
- Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment
- Radiotherapy
- Surgery
- Any other investigational drug in the 30 days before randomization
- Brain metastasis and/or leptomeningeal disease
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT00125034
Start Date
July 1 2005
End Date
November 1 2010
Last Update
August 7 2014
Active Locations (78)
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1
Research Site
Graz, Austria
2
Research Site
Linz, Austria
3
Research Site
Salzburg, Austria
4
Research Site
Vienna, Austria