Previously Untreated Metastatic Colorectal CancerPhase 2FUTURENCT00439517
Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.
A Phase 2 study testing UFOX + Cetuximab and FOLFOX4 + Cetuximab in people with Previously Untreated Metastatic Colorectal Cancer, run by Merck KGaA, Darmstadt, Germany at 57 sites in 14 countries.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previously Untreated Metastatic Colorectal Cancer
- What is being tested?
- UFOX + Cetuximab and FOLFOX4 + Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 57 sitesin 14 countries
- Study dates
- Feb 2007to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
57 sites in 14 countries.
57 sites in 14 countries
Germany13 sites
Research Site
Berlin
Research Site
Dortmund
Research Site
Dresden
Research Site
Frankfurt am Main
Research Site
Hamburg
Research Site
Hanover
Research Site
Heidelberg
Research Site
Kassel
Research Site
Krefeld
Research Site
Magdeburg
Research Site
München
Research Site
Oldenburg
Research Site
Wiesbaden
Italy11 sites
Research Site
Benevento
Research Site
Brescia
Research Site
Cremona
Research Site
Forlì
Research Site
Padova
Research Site
Pavia
Research Site
Potenza
Research Site
Reggio Emilia
Research Site
Rimini
Research Site
Roma
Research Site
Sassari
France8 sites
Research Site
Besançon
Research Site
Caen
Research Site
La Roche-sur-Yon
Research Site
Lille
Research Site
Marseille
Research Site
Nice
Research Site
Saint-Herblain
Research Site
Strasbourg
Poland4 sites
Research Site
Krakow
Research Site
Lublin
Research Site
Opole
Research Site
Warsaw
Brazil3 sites
Research Site
Belo Horizonte
Research site
Cep Sao Paulo-SP
Research Site
Fortaleza
Greece3 sites
Research Site
Dragana
Research Site
Thessaloniki
Research Site
Voútai
Argentina2 sites
Research Site
Buenos Aires
Research Site
Ciudad Autónoma Buenos Aires
About this study
Official title: 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)
- Being tested
- UFOX + Cetuximab, FOLFOX4 + Cetuximab
- Keywords
- Cancer, Colorectal, Metastatic, Untreated
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFOX + CetuximabDrug
- 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 + CetuximabDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | UFOX + Cetuximab Receives: Drug: UFOX + Cetuximab |
| 2 | Active comparator | FOLFOX4 + Cetuximab Receives: Drug: FOLFOX4 + Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
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
Measured: 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
Secondary outcomes (8)
Best Overall Response (BOR)
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
Measured: 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
Overall Survival (OS)
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.
Measured: 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
Overall Survival (OS)
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.
Measured: 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
Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
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.
Measured: 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
QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
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.
Measured: 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
QOL Therapy Preference Questionnaire (TPQ)
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.
Measured: 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
Treatment Impact on Social Daily Living and Health Care Resource Utilization
Non-protocol medical care visits and consultations
Measured: From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009
Safety - Number of Patients Experiencing Any Adverse Event
Please refer to Adverse Events section for details of individual serious adverse events and other adverse events
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2009
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Previously Untreated Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Yves Douillard, MD PhD, Principal investigator, Centre R Gauducheau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439517
- Sponsor's protocol ID
- EMR200025-001
- Acronym
- FUTURE
- Status last verified
- Jun 2014
- First submitted
- 22 Feb 2007
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24370353
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00439517
- Acronym / sponsor ID
- FUTURE / EMR200025-001
- Keywords
- Cancer, Colorectal, Metastatic, Untreated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Posted 14 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: UFOX + CetuximabUFOX + Cetuximab |
| 2 | Active comparator | Drug: FOLFOX4 + CetuximabFOLFOX4 + Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | 1 |
| 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 | Drug | 2 |
Primary outcome
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
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
8 secondary outcomes
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24370353Douillard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Yves Douillard, MD PhD principal investigator
Centre R Gauducheau
57 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UFOX + Cetuximab and FOLFOX4 + Cetuximab in people with Previously Untreated Metastatic Colorectal Cancer, run by Merck KGaA, Darmstadt, Germany at 57 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Germany, Italy, France, Poland, Brazil and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00439517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2014.