Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.
NCT ID: NCT00439517
Last Updated: 2014-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2007-02-28
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
UFOX + Cetuximab
UFOX + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
2
FOLFOX4 + Cetuximab
FOLFOX4 + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
Interventions
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UFOX + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
FOLFOX4 + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
Eligibility Criteria
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Inclusion Criteria
* Inpatient or outpatient ≥ 18 years of age
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* First occurrence of metastatic disease (not curatively resectable)
* Presence of at least one lesion measurable uni dimensionally by computerised tomography (CT) scan or magnetic resonance imaging (MRI). (Target lesion(s) must not lie within an irradiated area)
* Life expectancy of ≥ 3 months
* Karnofsky performance status of ≥ 60, at study entry
* White blood cell count (WBC) ≥ 3 x 10\^9/L, with neutrophils ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, and hemoglobin ≥ 9 g/dL
* Aspartate transaminase and alanine transaminase ≤ 2.5 x Upper Limit of Normal (ULN) (≤ 5 x ULN if liver metastasis are present)
* Normal serum creatinine (in case of elevated creatinine, labelled ethylenediaminetetraacetic acid clearance ≥ 65 mL/min is acceptable)
* Effective contraception for both male and female subjects if the risk of conception exists
* Tumor biopsy or archived sample available
Exclusion Criteria
* Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment.
* Previous oxaliplatin-based chemotherapy
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization
* Concurrent or previous chronic systemic immune therapy, targeted therapy, anti-vascular epithelial growth factor (VEGF) therapy, epidermal growth factor receptor (EGFR) pathway targeting therapy not indicated in the study protocol
* Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception
* Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
* Peripheral neuropathy \>grade 1
* Known hypersensitivity reaction to any of the components of the treatment.
* Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix. (Subjects with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the study)
* Pregnancy (absence to be confirmed by ß-human chorionic gonadotrophin test) or lactation period
* Known drug abuse/alcohol abuse
* Legal incapacity or limited legal capacity
* Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
* Participation in another clinical study within the 30 days before randomization
* Significant disease which, in the investigator's opinion, would exclude the subject from the study
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Yves Douillard, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre R Gauducheau
Locations
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Research Site
Buenos Aires, , Argentina
Research Site
Ciudad Autónoma Buenos Aires, , Argentina
Research Site
Perth, , Australia
Research Site
Wollongong, , Australia
Research Site
Graz, , Austria
Research Site
Vienna, , Austria
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Belo Horizonte, , Brazil
Research site
Cep Sao Paulo-SP, , Brazil
Research Site
Fortaleza, , Brazil
Research Site
Besançon, , France
Research Site
Caen, , France
Research Site
La Roche-sur-Yon, , France
Research Site
Lille, , France
Research Site
Marseille, , France
Research Site
Nice, , France
Research Site
Saint-Herblain, , France
Research Site
Strasbourg, , France
Research Site
Berlin, , Germany
Research Site
Dortmund, , Germany
Research Site
Dresden, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Hamburg, , Germany
Research Site
Hanover, , Germany
Research Site
Heidelberg, , Germany
Research Site
Kassel, , Germany
Research Site
Krefeld, , Germany
Research Site
Magdeburg, , Germany
Research Site
München, , Germany
Research Site
Oldenburg, , Germany
Research Site
Wiesbaden, , Germany
Research Site
Dragana, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Voútai, , Greece
Research Site
Hong Kong, , Hong Kong
Research Site
Shatin, , Hong Kong
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Benevento, , Italy
Research Site
Brescia, , Italy
Research Site
Cremona, , Italy
Research Site
Forlì, , Italy
Research Site
Padua, , Italy
Research Site
Pavia, , Italy
Research Site
Potenza, , Italy
Research Site
Reggio Emilia, , Italy
Research Site
Rimini, , Italy
Research Site
Roma, , Italy
Research Site
Sassari, , Italy
Research Site
Mexico City, , Mexico
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Opole, , Poland
Research Site
Warsaw, , Poland
Research Site
Bangkok, , Thailand
Research Site
Pathumwan, , Thailand
Countries
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References
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Douillard JY, Zemelka T, Fountzilas G, Barone C, Schlichting M, Heighway J, Eggleton SP, Srimuninnimit V. FOLFOX4 with cetuximab vs. UFOX with cetuximab as first-line therapy in metastatic colorectal cancer: The randomized phase II FUTURE study. Clin Colorectal Cancer. 2014 Mar;13(1):14-26.e1. doi: 10.1016/j.clcc.2013.11.009. Epub 2013 Nov 16.
Other Identifiers
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EMR200025-001
Identifier Type: -
Identifier Source: org_study_id
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