Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)
OPUS
Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
1 other identifier
interventional
344
13 countries
78
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 growth factor receptor (EGFR)-expressing mCRC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2005
Longer than P75 for phase_2
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 28, 2005
CompletedFirst Posted
Study publicly available on registry
July 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
October 4, 2011
CompletedAugust 7, 2014
August 1, 2011
1.7 years
July 28, 2005
August 23, 2011
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Overall Response Rate - Independent Review Committee (IRC)
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006
Secondary Outcomes (12)
Best Overall Response Rate (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population)
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
Best Overall Response Rate (KRAS Mutant Population)
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 1 Mar 2007
Progression-free Survival Time
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 01 Mar 2007
Progression-free Survival Time (KRAS Wild-Type Population)
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
Progression-free Survival Time (KRAS Mutant Population)
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 30 Nov 2008
- +7 more secondary outcomes
Study Arms (2)
Cetuximab Plus FOLFOX-4
EXPERIMENTALFOLFOX-4 Alone
ACTIVE COMPARATORInterventions
Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin folinic acid (FA) will be administered (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-Fluorouracil (5-FU) (as a bolus of 400 mg/m\^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops
Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m\^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m\^2/day IV over 2-4 minutes followed by 600 mg/m\^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops
Eligibility Criteria
You may qualify if:
- First-line mCRC
- EGFR positive
- Bi-dimensional measurable index lesion
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Research Site
Graz, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Zams, Austria
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Antwerp, Belgium
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Bonheiden, Belgium
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Bruges, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Roeselare, Belgium
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Turnhout, Belgium
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ZU Gent, Belgium
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Besançon, France
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Clermond Ferrand, France
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Clichy, France
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Montpellier, France
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Paris, France
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Rouen, France
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Strasbourg, France
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Aschaffenburg, Germany
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Dresden, Germany
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Essen, Germany
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Hamburg, Germany
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Kiel, Germany
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Magdeburg, Germany
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Mannheim, Germany
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Nuremberg, Germany
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Tübingen, Germany
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Athens, Greece
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Loannina, Greece
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Thessaloniki, Greece
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Haifa, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Brescia, Italy
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Milan, Italy
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Padua, Italy
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Pavia, Italy
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Rome, Italy
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Torino, Italy
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Bialystok, Poland
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Krakow, Poland
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Lublin, Poland
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Opole, Poland
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Poznan, Poland
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Szczecin, Poland
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Warsaw, Poland
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Lisbon, Portugal
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Santa Maira Da Feira, Portugal
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Alba Iulia, Romania
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Bucurest, Romania
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Onești, Romania
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Oradea, Romania
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Timișoara, Romania
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Kazan', Russia
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Krasnodar, Russia
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Moscow, Russia
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Obninsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Bilbao, Spain
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Burgos, Spain
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Girona, Spain
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Madrid, Spain
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Málaga, Spain
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Ourense, Spain
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Reus, Spain
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Valencia, Spain
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Dnipro, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Simferopol, Ukraine
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Vinnitsa, Ukraine
Related Publications (2)
Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, Donea S, Ludwig H, Schuch G, Stroh C, Loos AH, Zubel A, Koralewski P. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2009 Feb 10;27(5):663-71. doi: 10.1200/JCO.2008.20.8397. Epub 2008 Dec 29.
PMID: 19114683RESULTBokemeyer C, Bondarenko I, Hartmann JT, de Braud F, Schuch G, Zubel A, Celik I, Schlichting M, Koralewski P. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. Ann Oncol. 2011 Jul;22(7):1535-1546. doi: 10.1093/annonc/mdq632. Epub 2011 Jan 12.
PMID: 21228335RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A non-specific outcome measure 'Safety' was deleted from this entry in error. A replacement outcome has been created. The 'Safety' outcome refers to adverse events and these are shown in the 'Adverse Events' section.
Results Point of Contact
- Title
- Inmaculada Ollero/Clinical Trial Manager
- Organization
- Merck Serono
Study Officials
- PRINCIPAL INVESTIGATOR
Bokemeyer, Prof. Dr.
Klinik für Onkologie, Hämatologie und Knochenmarktransplantationen Universitätsklinikum Hamburg-Eppendorf, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2005
First Posted
July 29, 2005
Study Start
July 1, 2005
Primary Completion
March 1, 2007
Study Completion
November 1, 2010
Last Updated
August 7, 2014
Results First Posted
October 4, 2011
Record last verified: 2011-08