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Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab. (FUTURE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Merck KGaA.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00439517
First received: February 22, 2007
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Colorectal Cancer
Interventions: Drug: UFOX + Cetuximab
Drug: FOLFOX4 + Cetuximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject randomised 12 February 2007, last subject randomised 30 June 2008. Cut off date was 30th June 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 329 participants were screened and 302 participants were included in the Intent to Treat (ITT) Population. One patient included in the ITT population received no study medication and was not included in the Safety Population which comprised 301 participants (151 received UFOX plus cetuximab and 150 FOLFOX4 plus cetuximab).

Reporting Groups
  Description
UFOX + Cetuximab

UFOX is a combination regimen of UFT® (Tegafur and Uracil), Oxaliplatin and Folinic Acid.

  • 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

FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.

  • 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

Participant Flow:   Overall Study
    UFOX + Cetuximab     FOLFOX4 + Cetuximab  
STARTED     152     150  
COMPLETED     144     139  
NOT COMPLETED     8     11  
Ongoing at cut-off date                 8                 11  



  Baseline Characteristics
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Reporting Groups
  Description
UFOX + Cetuximab

UFOX is a combination regimen of UFT® (Tegafur and Uracil), Oxaliplatin and Folinic Acid.

  • 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

FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.

  • 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
Total Total of all reporting groups

Baseline Measures
    UFOX + Cetuximab     FOLFOX4 + Cetuximab     Total  
Number of Participants  
[units: participants]
 		  152     150     302  
Age  
[units: years]
Mean ± Standard Deviation 		  60.1  ± 10.01     61  ± 11.04     60.5  ± 10.53  
Age, Customized  
[units: participants]
 		     
<65 years     93     84     177  
>=65 years     57     66     123  
Missing     2     0     2  
Gender  
[units: participants]
 		     
Female     57     55     112  
Male     95     95     190  
Region of Enrollment  
[units: participants]
 		     
Hong Kong     7     4     11  
Greece     9     5     14  
Thailand     7     9     16  
Austria     13     9     22  
Italy     28     33     61  
France     6     8     14  
Mexico     4     0     4  
Argentina     5     6     11  
Brazil     5     9     14  
Poland     30     27     57  
Belgium     5     7     12  
Australia     6     5     11  
Germany     27     28     55  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009 ]
  Show Outcome Measure 1

2.  Secondary:   Best Overall Response (BOR)   [ Time Frame: Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009 ]
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3.  Secondary:   Overall Survival (OS)   [ Time Frame: Time from randomization to death or last known to be alive, reported between day of first patient randomised, Dec 2006, until cut off date, 30 Jun 2009 ]
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4.  Secondary:   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, Dec 2006, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays ]
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5.  Secondary:   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, Dec 2006, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays ]
  Show Outcome Measure 5

6.  Secondary:   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, Dec 2006, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays ]
  Show Outcome Measure 6

7.  Secondary:   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, Dec 2006, until cut-off date, 30 Jun 2009 ]
  Show Outcome Measure 7

8.  Secondary:   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, Dec 2006, until cut off date, 30 Jun 2009 ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Heike Pausch
Organization: Merck KGaA
phone: +49 (0) 6151 72 6713
e-mail: heike.pausch@merck.de


No publications provided


Responsible Party: Heike Pausch, Merck KGaA
ClinicalTrials.gov Identifier: NCT00439517     History of Changes
Other Study ID Numbers: EMR200025-001
Study First Received: February 22, 2007
Results First Received: March 31, 2011
Last Updated: May 13, 2011
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)