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Trial record 14 of 19 for:    colon cancer | ( Map: Mexico )

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

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ClinicalTrials.gov Identifier: NCT00439517
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : June 14, 2011
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Previously Untreated Metastatic Colorectal Cancer
Interventions Drug: UFOX + Cetuximab
Drug: FOLFOX4 + Cetuximab
Enrollment 302
Recruitment Details First subject randomised 12 February 2007, last subject randomised 30 June 2008. Cut off date was 30th June 2009
Pre-assignment Details 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).
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
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UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Period Title: Overall Study
Started 152 150
Completed 150 150
Not Completed 2 0
Reason Not Completed
Subject on treatment             1             0
Subject in survival follow-up             1             0
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab Total
Hide Arm/Group Description

UFOX is a combination regimen of UFT® (Tegafur plus 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 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 of all reporting groups
Overall Number of Baseline Participants 152 150 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 152 participants 150 participants 302 participants
60.1  (10.01) 61  (11.04) 60.5  (10.53)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 participants
<65 years 93 84 177
>=65 years 57 66 123
Missing 2 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 participants
Female
57
  37.5%
55
  36.7%
112
  37.1%
Male
95
  62.5%
95
  63.3%
190
  62.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 152 participants 150 participants 302 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
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description 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
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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Hide Analysis Population Description
Intention-to-treat (ITT) population i.e. all randomized subjects .
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 152 150
Median (95% Confidence Interval)
Unit of Measure: months
6.6
(5.6 to 7.2)
8.2
(7.5 to 9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UFOX + Cetuximab, FOLFOX4 + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.677
Confidence Interval (2-Sided) 95%
0.515 to 0.889
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Best Overall Response (BOR)
Hide Description 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
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population i.e. all randomized subjects.
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 152 150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.5
(29.8 to 45.7)
51.3
(43.0 to 59.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UFOX + Cetuximab, FOLFOX4 + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified odds ratio and Cochran-Mantel- Haenszel (CMH) statistics were calculated considering the randomization strata.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.756
Confidence Interval (2-Sided) 95%
1.110 to 2.777
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population i.e. all randomized subjects.
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 152 150
Median (95% Confidence Interval)
Unit of Measure: months
12.9
(11.5 to 15.8)
15.5
(12.6 to 18.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UFOX + Cetuximab, FOLFOX4 + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3797
Comments [Not Specified]
Method Stratified log rank
Comments Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.855
Confidence Interval (2-Sided) 95%
0.603 to 1.213
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population i.e. all randomized subjects.
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 152 150
Median (95% Confidence Interval)
Unit of Measure: months
16.8
(13.9 to 18.5)
18.4
(15.3 to 20.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UFOX + Cetuximab, FOLFOX4 + Cetuximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8575
Comments [Not Specified]
Method Stratified log rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.977
Confidence Interval (2-Sided) 95%
0.755 to 1.263
Estimation Comments Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
5.Secondary Outcome
Title Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were considered evaluable for FACT-C provided they had at least one evaluable FACT-C questionnaire and provided that they were also included in the ITT Population
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 137 132
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline 98.22  (1.725) 96.45  (1.749)
Cycle 3 95.41  (1.735) 95.89  (1.806)
Cycle 6 94.75  (2.090) 94.70  (2.126)
6.Secondary Outcome
Title QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were considered evaluable for EQ-5D provided they had at least one evaluable EQ-5D questionnaire and provided that they were also included in the ITT Population.
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 136 130
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline 0.747  (0.021) 0.734  (0.021)
Cycle 3 0.782  (0.021) 0.758  (0.022)
Cycle 6 0.758  (0.026) 0.771  (0.026)
7.Secondary Outcome
Title QOL Therapy Preference Questionnaire (TPQ)
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description

Patients were considered evaluable for TPQ provided they had at least one evaluable TPQ questionnaire and they were also included in the ITT TPQ subset population.

The most essential characteristics of a cancer medication score are shown at baseline and cycle 3, no further cycles are available due to the low number of patients in later cycles

Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 99 99
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: Does not increase your risk of infection 18 16
Baseline: Does not interfere with daily activities 17 15
Baseline: Does not make you vomit 4 14
Baseline: Does not give you diarrhea 9 5
Cycle 3: Does not increase your risk of infection 15 15
Cycle 3: Does not interfere with daily activities 10 11
Cycle 3: Does not make you vomit 4 10
Cycle 3: Does not give you diarrhea 15 4
8.Secondary Outcome
Title Treatment Impact on Social Daily Living and Health Care Resource Utilization
Hide Description Non-protocol medical care visits and consultations
Time Frame From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 152 150
Measure Type: Number
Unit of Measure: visits or consultations
Emergency room visit 34 26
Hospital oupatient clinic visit 40 35
Practice visit 71 159
Home visit 15 130
General Practitioner consultation 65 124
Specialist consultation 62 84
Nurse consultation 15 123
Other consultation 19 18
9.Secondary Outcome
Title Safety - Number of Patients Experiencing Any Adverse Event
Hide Description Please refer to Adverse Events section for details of individual serious adverse events and other adverse events
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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description:

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
Overall Number of Participants Analyzed 151 150
Measure Type: Number
Unit of Measure: participants
151 149
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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title UFOX + Cetuximab FOLFOX4 + Cetuximab
Hide Arm/Group Description

UFOX is a combination regimen of UFT® (Tegafur plus 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 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
All-Cause Mortality
UFOX + Cetuximab FOLFOX4 + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
UFOX + Cetuximab FOLFOX4 + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   52/151 (34.44%)   48/150 (32.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/151 (0.66%)  1/150 (0.67%) 
Coagulopathy  1  1/151 (0.66%)  0/150 (0.00%) 
Febrile neutropenia  1  0/151 (0.00%)  2/150 (1.33%) 
Neutropenia  1  0/151 (0.00%)  2/150 (1.33%) 
Splenic vein thrombosis  1  1/151 (0.66%)  0/150 (0.00%) 
Thrombocytopenia  1  0/151 (0.00%)  1/150 (0.67%) 
Cardiac disorders     
Cardiac failure  1  0/151 (0.00%)  1/150 (0.67%) 
Myocardial infarction  1  1/151 (0.66%)  0/150 (0.00%) 
Eye disorders     
Ulcerative keratitis  1  0/151 (0.00%)  1/150 (0.67%) 
Gastrointestinal disorders     
Abdominal pain  1  5/151 (3.31%)  4/150 (2.67%) 
Anal fistula  1  1/151 (0.66%)  0/150 (0.00%) 
Colitis  1  1/151 (0.66%)  0/150 (0.00%) 
Diarrhoea  1  13/151 (8.61%)  4/150 (2.67%) 
Faecaloma  1  0/151 (0.00%)  1/150 (0.67%) 
Gastrointestinal obstruction  1  0/151 (0.00%)  1/150 (0.67%) 
Ileus  1  5/151 (3.31%)  2/150 (1.33%) 
Intestinal obstruction  1  5/151 (3.31%)  2/150 (1.33%) 
Nausea  1  4/151 (2.65%)  0/150 (0.00%) 
Proctalgia  1  1/151 (0.66%)  0/150 (0.00%) 
Rectal haemorrhage  1  1/151 (0.66%)  0/150 (0.00%) 
Stomatitis  1  0/151 (0.00%)  1/150 (0.67%) 
Subileus  1  1/151 (0.66%)  0/150 (0.00%) 
Vomiting  1  9/151 (5.96%)  3/150 (2.00%) 
General disorders     
Asthenia  1  0/151 (0.00%)  1/150 (0.67%) 
Chills  1  1/151 (0.66%)  0/150 (0.00%) 
Fatigue  1  1/151 (0.66%)  2/150 (1.33%) 
General physical health deterioration  1  0/151 (0.00%)  4/150 (2.67%) 
Inflammation  1  1/151 (0.66%)  0/150 (0.00%) 
Pyrexia  1  3/151 (1.99%)  8/150 (5.33%) 
Hepatobiliary disorders     
Biliary colic  1  1/151 (0.66%)  0/150 (0.00%) 
Cholecystitis  1  0/151 (0.00%)  1/150 (0.67%) 
Hepatic failure  1  1/151 (0.66%)  0/150 (0.00%) 
Hepatorenal syndrome  1  1/151 (0.66%)  0/150 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  0/151 (0.00%)  2/150 (1.33%) 
Infections and infestations     
Anal abscess  1  1/151 (0.66%)  0/150 (0.00%) 
Catheter related infection  1  0/151 (0.00%)  1/150 (0.67%) 
Cellulitis  1  0/151 (0.00%)  1/150 (0.67%) 
Central line infection  1  1/151 (0.66%)  5/150 (3.33%) 
Clostridium difficile colitis  1  0/151 (0.00%)  1/150 (0.67%) 
Hepatitis C  1  1/151 (0.66%)  0/150 (0.00%) 
Pneumonia  1  1/151 (0.66%)  1/150 (0.67%) 
Pyelonephritis  1  0/151 (0.00%)  1/150 (0.67%) 
Pyelonephritis acute  1  1/151 (0.66%)  0/150 (0.00%) 
Rectal abscess  1  1/151 (0.66%)  0/150 (0.00%) 
Septic shock  1  1/151 (0.66%)  2/150 (1.33%) 
Urinary tract infection  1  0/151 (0.00%)  2/150 (1.33%) 
Urosepsis  1  0/151 (0.00%)  1/150 (0.67%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/151 (0.66%)  0/150 (0.00%) 
Overdose  1  1/151 (0.66%)  2/150 (1.33%) 
Post procedural haemorrhage  1  1/151 (0.66%)  0/150 (0.00%) 
Investigations     
Blood glucose abnormal  1  0/151 (0.00%)  1/150 (0.67%) 
Metabolism and nutrition disorders     
Anorexia  1  1/151 (0.66%)  1/150 (0.67%) 
Dehydration  1  2/151 (1.32%)  1/150 (0.67%) 
Hyperglycaemia  1  1/151 (0.66%)  0/150 (0.00%) 
Hypocalcaemia  1  0/151 (0.00%)  1/150 (0.67%) 
Hypokalaemia  1  2/151 (1.32%)  0/150 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/151 (0.66%)  0/150 (0.00%) 
Back pain  1  1/151 (0.66%)  0/150 (0.00%) 
Pathological fracture  1  1/151 (0.66%)  0/150 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant ascites  1  0/151 (0.00%)  1/150 (0.67%) 
Metastases to central nervous system  1  1/151 (0.66%)  0/150 (0.00%) 
Nervous system disorders     
Cerebral ischaemia  1  0/151 (0.00%)  1/150 (0.67%) 
Coma hepatic  1  1/151 (0.66%)  0/150 (0.00%) 
Grand mal convulsion  1  1/151 (0.66%)  0/150 (0.00%) 
Headache  1  0/151 (0.00%)  1/150 (0.67%) 
Syncope  1  0/151 (0.00%)  2/150 (1.33%) 
Psychiatric disorders     
Anxiety  1  0/151 (0.00%)  1/150 (0.67%) 
Confusional state  1  1/151 (0.66%)  0/150 (0.00%) 
Renal and urinary disorders     
Hydronephrosis  1  1/151 (0.66%)  0/150 (0.00%) 
Renal failure acute  1  1/151 (0.66%)  0/150 (0.00%) 
Ureteric perforation  1  0/151 (0.00%)  1/150 (0.67%) 
Urethral disorder  1  1/151 (0.66%)  0/150 (0.00%) 
Urinary bladder haemorrhage  1  0/151 (0.00%)  1/150 (0.67%) 
Urinary retention  1  0/151 (0.00%)  1/150 (0.67%) 
Reproductive system and breast disorders     
Vaginal fistula  1  0/151 (0.00%)  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/151 (0.66%)  2/150 (1.33%) 
Haemoptysis  1  0/151 (0.00%)  1/150 (0.67%) 
Pleural effusion  1  0/151 (0.00%)  1/150 (0.67%) 
Pneumonitis  1  0/151 (0.00%)  2/150 (1.33%) 
Pulmonary artery thrombosis  1  0/151 (0.00%)  1/150 (0.67%) 
Pulmonary embolism  1  1/151 (0.66%)  2/150 (1.33%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  1/151 (0.66%)  0/150 (0.00%) 
Vascular disorders     
Arterial thrombosis  1  0/151 (0.00%)  1/150 (0.67%) 
Circulatory collapse  1  0/151 (0.00%)  1/150 (0.67%) 
Femoral artery embolism  1  1/151 (0.66%)  0/150 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
UFOX + Cetuximab FOLFOX4 + Cetuximab
Affected / at Risk (%) Affected / at Risk (%)
Total   151/151 (100.00%)   146/150 (97.33%) 
Blood and lymphatic system disorders     
Neutropenia  1  10/151 (6.62%)  65/150 (43.33%) 
Thrombocytopenia  1  33/151 (21.85%)  37/150 (24.67%) 
Leukopenia  1  5/151 (3.31%)  28/150 (18.67%) 
Anaemia  1  15/151 (9.93%)  26/150 (17.33%) 
Eye disorders     
Conjunctivitis  1  14/151 (9.27%)  14/150 (9.33%) 
Gastrointestinal disorders     
Diarrhoea  1  79/151 (52.32%)  72/150 (48.00%) 
Nausea  1  67/151 (44.37%)  55/150 (36.67%) 
Stomatitis  1  15/151 (9.93%)  36/150 (24.00%) 
Vomiting  1  40/151 (26.49%)  32/150 (21.33%) 
Constipation  1  29/151 (19.21%)  30/150 (20.00%) 
Abdominal pain  1  34/151 (22.52%)  25/150 (16.67%) 
Abdominal pain upper  1  10/151 (6.62%)  8/150 (5.33%) 
Dyspepsia  1  10/151 (6.62%)  8/150 (5.33%) 
Flatulence  1  9/151 (5.96%)  1/150 (0.67%) 
General disorders     
Fatigue  1  38/151 (25.17%)  38/150 (25.33%) 
Pyrexia  1  30/151 (19.87%)  36/150 (24.00%) 
Mucosal inflammation  1  15/151 (9.93%)  34/150 (22.67%) 
Asthenia  1  25/151 (16.56%)  27/150 (18.00%) 
Oedema peripheral  1  11/151 (7.28%)  11/150 (7.33%) 
Chills  1  5/151 (3.31%)  9/150 (6.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  12/151 (7.95%)  6/150 (4.00%) 
Immune system disorders     
Drug hypersensitivity  1  12/151 (7.95%)  10/150 (6.67%) 
Hypersensitivity  1  3/151 (1.99%)  8/150 (5.33%) 
Infections and infestations     
Paronychia  1  26/151 (17.22%)  33/150 (22.00%) 
Folliculitis  1  8/151 (5.30%)  14/150 (9.33%) 
Nasopharyngitis  1  6/151 (3.97%)  11/150 (7.33%) 
Pharyngitis  1  8/151 (5.30%)  7/150 (4.67%) 
Investigations     
Weight decreased  1  12/151 (7.95%)  16/150 (10.67%) 
Alanine aminotransferase increased  1  9/151 (5.96%)  8/150 (5.33%) 
Platelet count decreased  1  9/151 (5.96%)  6/150 (4.00%) 
Aspartate aminotransferase increased  1  10/151 (6.62%)  5/150 (3.33%) 
Metabolism and nutrition disorders     
Anorexia  1  40/151 (26.49%)  36/150 (24.00%) 
Hypokalaemia  1  17/151 (11.26%)  15/150 (10.00%) 
Hypomagnesaemia  1  15/151 (9.93%)  14/150 (9.33%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  10/151 (6.62%)  10/150 (6.67%) 
Pain in extremity  1  5/151 (3.31%)  8/150 (5.33%) 
Nervous system disorders     
Paraesthesia  1  38/151 (25.17%)  43/150 (28.67%) 
Peripheral sensory neuropathy  1  29/151 (19.21%)  27/150 (18.00%) 
Neuropathy peripheral  1  17/151 (11.26%)  22/150 (14.67%) 
Dysgeusia  1  13/151 (8.61%)  20/150 (13.33%) 
Polyneuropathy  1  6/151 (3.97%)  17/150 (11.33%) 
Headache  1  6/151 (3.97%)  10/150 (6.67%) 
Dysaesthesia  1  11/151 (7.28%)  5/150 (3.33%) 
Psychiatric disorders     
Insomnia  1  9/151 (5.96%)  5/150 (3.33%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  9/151 (5.96%)  13/150 (8.67%) 
Dyspnoea  1  5/151 (3.31%)  8/150 (5.33%) 
Cough  1  8/151 (5.30%)  7/150 (4.67%) 
Skin and subcutaneous tissue disorders     
Rash  1  63/151 (41.72%)  47/150 (31.33%) 
Dermatitis acneiform  1  40/151 (26.49%)  45/150 (30.00%) 
Dry skin  1  27/151 (17.88%)  29/150 (19.33%) 
Skin fissures  1  13/151 (8.61%)  22/150 (14.67%) 
Pruritus  1  8/151 (5.30%)  15/150 (10.00%) 
Acne  1  20/151 (13.25%)  14/150 (9.33%) 
Palmar-plantar erythrodysaesthesia syndrome  1  10/151 (6.62%)  13/150 (8.67%) 
Alopecia  1  6/151 (3.97%)  13/150 (8.67%) 
Erythema  1  10/151 (6.62%)  12/150 (8.00%) 
Nail disorder  1  7/151 (4.64%)  11/150 (7.33%) 
Dermatitis  1  5/151 (3.31%)  9/150 (6.00%) 
Vascular disorders     
Hypertension  1  8/151 (5.30%)  11/150 (7.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Dosing of UFT/ folinic acid in the experimental arm were not directly recorded, so dosing data is not fully available in the UFOX plus cetuximab arm (36/151). Comparative conclusions on drug exposure might be impacted by a bias due to missing data.
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck KGaA
Phone: +49-6151-75-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00439517     History of Changes
Other Study ID Numbers: EMR200025-001
First Submitted: February 22, 2007
First Posted: February 23, 2007
Results First Submitted: March 31, 2011
Results First Posted: June 14, 2011
Last Update Posted: June 27, 2014