- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439517
Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab. (FUTURE)
June 18, 2014 updated by: Merck KGaA, Darmstadt, Germany
A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.
This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
302
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
- Research Site
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Ciudad Autónoma Buenos Aires, Argentina
- Research Site
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Perth, Australia
- Research Site
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Wollongong, Australia
- Research Site
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Graz, Austria
- Research Site
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Wien, Austria
- Research Site
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Leuven, Belgium
- Research Site
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Liège, Belgium
- Research Site
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Belo Horizonte, Brazil
- Research Site
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Cep Sao Paulo-SP, Brazil
- Research Site
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Fortaleza, Brazil
- Research Site
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Besancon Cedex, France
- Research Site
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Caen-Cedex 5, France
- Research Site
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La Roche sur Yon, France
- Research Site
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Lille, France
- Research Site
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Marseille, France
- Research Site
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Nice, France
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Saint-Herblain, France
- Research Site
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Strasbourg, France
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Berlin, Germany
- Research Site
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Dortmund, Germany
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Dresden, Germany
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Frankfurt / Main, Germany
- Research Site
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Hamburg, Germany
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Hannover, Germany
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Heidelberg, Germany
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Kassel, Germany
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Krefeld, Germany
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Magdeburg, Germany
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München, Germany
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Oldenburg, Germany
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Wiesbaden, Germany
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Dragana, Greece
- Research Site
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Thessaloniki, Greece
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Voutes, Greece
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Hong Kong, Hong Kong
- Research Site
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Sha Tin, Hong Kong
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Haifa, Israel
- Research Site
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Jerusalem, Israel
- Research Site
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Benevento, Italy
- Research Site
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Brescia, Italy
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Cremona, Italy
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Forli, Italy
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Padova, Italy
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Pavia, Italy
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Potenza, Italy
- Research Site
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Reggio Emilia, Italy
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Rimini, Italy
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Roma, Italy
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Sassari, Italy
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Mexico-City, Mexico
- Research Site
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Krakow, Poland
- Research Site
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Lublin, Poland
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Opole, Poland
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Warsaw, Poland
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Bangkok, Thailand
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Pathumwan, Thailand
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Signed written informed consent
- 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:
- Brain metastasis and/or leptomeningeal disease (known or suspected)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
UFOX + Cetuximab
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Active Comparator: 2
FOLFOX4 + Cetuximab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression-free Survival (PFS)
Time Frame: Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Duration from randomization until progression or death due to any cause.
Only deaths within 12 weeks of last tumor assessment are considered.
Patients without event are censored on the date of last tumor assessment.
Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria
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Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Best Overall Response (BOR)
Time Frame: Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest.
CR defined as "Disappearance of all target lesions plus disappearance of all non-target lesions & without appearance of any new lesions; confirmed minimum 4 weeks later.
PR defined as "At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later
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Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Overall Survival (OS)
Time Frame: Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Time from randomization to death.
Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Overall Survival (OS)
Time Frame: Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011
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Time from randomization to death.
Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011
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Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Time Frame: At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays
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All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0="Not at all" to 4="Very much".
For scoring purposes the response scores are reversed on negatively phrased questions.
The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered.
The lowest possible total score is 0 and the highest is 136.
A high scale score represents a high QOL.
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At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays
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QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
Time Frame: at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
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The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value.
The optional part of the questionnaire was not applied.
The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The 5 items are combined to generate health profiles.
These profiles were converted to a continuous single index score using a one to one matching.
The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.
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at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
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QOL Therapy Preference Questionnaire (TPQ)
Time Frame: at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
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TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction.
The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.
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at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
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Treatment Impact on Social Daily Living and Health Care Resource Utilization
Time Frame: From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009
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Non-protocol medical care visits and consultations
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From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009
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Safety - Number of Patients Experiencing Any Adverse Event
Time Frame: Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Please refer to Adverse Events section for details of individual serious adverse events and other adverse events
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Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Yves Douillard, MD PhD, Centre R Gauducheau
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
February 22, 2007
First Submitted That Met QC Criteria
February 22, 2007
First Posted (Estimate)
February 23, 2007
Study Record Updates
Last Update Posted (Estimate)
June 27, 2014
Last Update Submitted That Met QC Criteria
June 18, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR200025-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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