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A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients (TAILOR)

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ClinicalTrials.gov Identifier: NCT01228734
Recruitment Status : Completed
First Posted : October 26, 2010
Results First Posted : March 6, 2017
Last Update Posted : January 28, 2020
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 Metastatic Colorectal Cancer
Interventions Drug: Cetuximab
Drug: Oxaliplatin
Drug: Folinic Acid
Drug: 5Fluorouracil
Enrollment 553
Recruitment Details The study was planned to enroll subjects with Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type (wt) tumors.Following modification of approved EU indication of cetuximab,a decision made to amend study population from subjects with KRAS wt tumors to those with RAS wt tumors. All efficacy/safety analysis based on subjects with RAS wt tumor.
Pre-assignment Details First subject first visit/last subject last visit: 30 September 2010/31 Jan 2018. A total of 553 subjects were enrolled in the trial. 504 subjects were randomized in the study, of which 397 were with RAS wt tumors. Participant Flow is presented for the subjects with RAS wt tumors.
Arm/Group Title Cetuximab + FOLFOX4 FOLFOX4
Hide Arm/Group Description Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity. Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Period Title: Overall Study
Started 193 204
Modified Intent-to-treat Population 193 200
Modified Safety Population 194 [1] 199
Completed 193 200
Not Completed 0 4
Reason Not Completed
Randomized, but not treated             0             4
[1]
One subject was randomized to FOLFOX-4 group but received cetuximab + FOLFOX-4 treatment instead
Arm/Group Title Cetuximab + FOLFOX-4 FOLFOX-4 Total
Hide Arm/Group Description Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity. Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 193 200 393
Hide Baseline Analysis Population Description
Modified intent-to-treat (MITT) population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants 200 participants 393 participants
54.8  (11.8) 55.1  (11.2) 54.9  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 200 participants 393 participants
Female
66
  34.2%
61
  30.5%
127
  32.3%
Male
127
  65.8%
139
  69.5%
266
  67.7%
1.Primary Outcome
Title Progression Free Survival (PFS) Time
Hide Description PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.
Time Frame Baseline up to 333 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.
Arm/Group Title Cetuximab + FOLFOX-4 FOLFOX-4
Hide Arm/Group Description:
Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Overall Number of Participants Analyzed 193 200
Median (95% Confidence Interval)
Unit of Measure: months
9.2
(8.8 to 10.9)
7.4
(5.8 to 7.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cetuximab + FOLFOX-4, FOLFOX-4
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.629
Confidence Interval (2-Sided) 95%
0.498 to 0.794
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS) Time
Hide Description OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.
Time Frame Baseline up to 333 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.
Arm/Group Title Cetuximab + FOLFOX-4 FOLFOX-4
Hide Arm/Group Description:
Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Overall Number of Participants Analyzed 193 200
Median (95% Confidence Interval)
Unit of Measure: months
20.8
(16.3 to 23.5)
16.5
(14.8 to 19.5)
3.Secondary Outcome
Title Best Overall Response Rate (ORR)
Hide Description The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.
Time Frame Baseline up to 333 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.
Arm/Group Title Cetuximab + FOLFOX-4 FOLFOX-4
Hide Arm/Group Description:
Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
66.3
(59.2 to 72.9)
40.5
(33.6 to 47.7)
4.Secondary Outcome
Title Time to Treatment Failure (TTF)
Hide Description TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator's assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment.
Time Frame Baseline up to 333 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.
Arm/Group Title Cetuximab + FOLFOX-4 FOLFOX-4
Hide Arm/Group Description:
Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Overall Number of Participants Analyzed 193 200
Median (95% Confidence Interval)
Unit of Measure: months
9.2
(7.4 to 9.3)
5.6
(5.6 to 6.5)
5.Secondary Outcome
Title Number of Subjects With Curative Surgery of Liver Metastases
Hide Description The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.
Time Frame Baseline up to 333 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized. Here "Number Analyzed" signifies those subjects who were evaluable for the specified categories.
Arm/Group Title Cetuximab + FOLFOX-4 FOLFOX-4
Hide Arm/Group Description:
Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
Overall Number of Participants Analyzed 193 200
Measure Type: Number
Unit of Measure: subjects
Subjects with liver surgery 9 6
Subjects with liver surgery outcome: R0 7 2
Subjects with liver surgery outcome: R1 1 2
Subjects with liver surgery outcome: R2 0 0
Subjects not evaluable 0 0
Time Frame Baseline up to Safety Follow up (assessed up to 333 weeks)
Adverse Event Reporting Description Modified safety population included all subjects with RAS wild type tumor status who received any study treatment (cetuximab, oxaliplatin or 5-FU/FA). Subjects were analyzed as treated.
 
Arm/Group Title Cetuximab + FOLFOX-4 FOLFOX-4
Hide Arm/Group Description Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity. Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
All-Cause Mortality
Cetuximab + FOLFOX-4 FOLFOX-4
Affected / at Risk (%) Affected / at Risk (%)
Total   157/194 (80.93%)   173/199 (86.93%) 
Hide Serious Adverse Events
Cetuximab + FOLFOX-4 FOLFOX-4
Affected / at Risk (%) Affected / at Risk (%)
Total   42/194 (21.65%)   27/199 (13.57%) 
Blood and lymphatic system disorders     
BONE MARROW FAILURE * 1  1/194 (0.52%)  1/199 (0.50%) 
FEBRILE NEUTROPENIA * 1  1/194 (0.52%)  0/199 (0.00%) 
LEUKOPENIA * 1  1/194 (0.52%)  0/199 (0.00%) 
NEUTROPENIA * 1  1/194 (0.52%)  1/199 (0.50%) 
THROMBOCYTOPENIA * 1  0/194 (0.00%)  2/199 (1.01%) 
THROMBOCYTOPENIC PURPURA * 1  0/194 (0.00%)  2/199 (1.01%) 
THROMBOCYTOPENIC PURPURA * 1  0/194 (0.00%)  1/199 (0.50%) 
Cardiac disorders     
ATRIAL FLUTTER * 1  0/194 (0.00%)  1/199 (0.50%) 
VENTRICULAR TACHYCARDIA * 1  1/194 (0.52%)  0/199 (0.00%) 
Eye disorders     
RETINAL DETACHMENT * 1  1/194 (0.52%)  0/199 (0.00%) 
Gastrointestinal disorders     
ABDOMINAL PAIN * 1  1/194 (0.52%)  0/199 (0.00%) 
ANAL FISTULA * 1  1/194 (0.52%)  0/199 (0.00%) 
DIARRHOEA * 1  1/194 (0.52%)  0/199 (0.00%) 
ENTERITIS * 1  1/194 (0.52%)  0/199 (0.00%) 
INCARCERATED INGUINAL HERNIA * 1  1/194 (0.52%)  0/199 (0.00%) 
INTESTINAL OBSTRUCTION * 1  7/194 (3.61%)  4/199 (2.01%) 
INTESTINAL PERFORATION * 1  1/194 (0.52%)  0/199 (0.00%) 
LARGE INTESTINAL OBSTRUCTION * 1  1/194 (0.52%)  0/199 (0.00%) 
SMALL INTESTINAL OBSTRUCTION * 1  0/194 (0.00%)  1/199 (0.50%) 
LARGE INTESTINE POLYP * 1  1/194 (0.52%)  0/199 (0.00%) 
General disorders     
MULTI-ORGAN FAILURE * 1  3/194 (1.55%)  3/199 (1.51%) 
PYREXIA * 1  0/194 (0.00%)  1/199 (0.50%) 
SUDDEN DEATH * 1  1/194 (0.52%)  0/199 (0.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS * 1  0/194 (0.00%)  1/199 (0.50%) 
HEPATIC FAILURE * 1  2/194 (1.03%)  0/199 (0.00%) 
HYPERBILIRUBINAEMIA * 1  1/194 (0.52%)  1/199 (0.50%) 
JAUNDICE CHOLESTATIC * 1  0/194 (0.00%)  1/199 (0.50%) 
Immune system disorders     
DRUG HYPERSENSITIVITY * 1  2/194 (1.03%)  1/199 (0.50%) 
Infections and infestations     
ANAL ABSCESS * 1  0/194 (0.00%)  1/199 (0.50%) 
EPIDIDYMITIS * 1  1/194 (0.52%)  0/199 (0.00%) 
INFECTION * 1  0/194 (0.00%)  1/199 (0.50%) 
LOWER RESPIRATORY TRACT INFECTION * 1  1/194 (0.52%)  0/199 (0.00%) 
PNEUMONIA * 1  1/194 (0.52%)  1/199 (0.50%) 
SEPTIC SHOCK * 1  1/194 (0.52%)  0/199 (0.00%) 
SKIN INFECTION * 1  1/194 (0.52%)  1/199 (0.50%) 
STAPHYLOCOCCAL BACTERAEMIA * 1  0/194 (0.00%)  1/199 (0.50%) 
STAPHYLOCOCCAL INFECTION * 1  1/194 (0.52%)  0/199 (0.00%) 
INFUSION SITE INFECTION * 1  1/194 (0.52%)  0/199 (0.00%) 
RESPIRATORY TRACT INFECTION * 1  1/194 (0.52%)  1/199 (0.50%) 
Investigations     
HAEMOGLOBIN DECREASED * 1  1/194 (0.52%)  0/199 (0.00%) 
ALANINE AMINOTRANSFERASE INCREASED * 1  1/194 (0.52%)  0/199 (0.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/194 (0.52%)  0/199 (0.00%) 
Metabolism and nutrition disorders     
TYPE 2 DIABETES MELLITUS * 1  1/194 (0.52%)  0/199 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
COLON CANCER METASTATIC * 1  1/194 (0.52%)  0/199 (0.00%) 
Nervous system disorders     
CEREBRAL INFARCTION * 1  0/194 (0.00%)  2/199 (1.01%) 
HEADACHE * 1  0/194 (0.00%)  1/199 (0.50%) 
HEPATIC ENCEPHALOPATHY * 1  1/194 (0.52%)  0/199 (0.00%) 
SYNCOPE * 1  1/194 (0.52%)  0/199 (0.00%) 
Psychiatric disorders     
SUICIDE ATTEMPT * 1  1/194 (0.52%)  0/199 (0.00%) 
Renal and urinary disorders     
RENAL FAILURE * 1  1/194 (0.52%)  0/199 (0.00%) 
URETERIC OBSTRUCTION * 1  2/194 (1.03%)  0/199 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA AT REST * 1  2/194 (1.03%)  0/199 (0.00%) 
Vascular disorders     
AXILLARY VEIN THROMBOSIS * 1  1/194 (0.52%)  0/199 (0.00%) 
DEEP VEIN THROMBOSIS * 1  1/194 (0.52%)  0/199 (0.00%) 
JUGULAR VEIN THROMBOSIS * 1  1/194 (0.52%)  0/199 (0.00%) 
PHLEBITIS * 1  0/194 (0.00%)  2/199 (1.01%) 
SUBCLAVIAN VEIN THROMBOSIS * 1  1/194 (0.52%)  0/199 (0.00%) 
VENOUS THROMBOSIS LIMB * 1  2/194 (1.03%)  1/199 (0.50%) 
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab + FOLFOX-4 FOLFOX-4
Affected / at Risk (%) Affected / at Risk (%)
Total   194/194 (100.00%)   194/199 (97.49%) 
Blood and lymphatic system disorders     
ANAEMIA * 1  28/194 (14.43%)  24/199 (12.06%) 
BONE MARROW FAILURE * 1  18/194 (9.28%)  14/199 (7.04%) 
LEUKOPENIA * 1  151/194 (77.84%)  146/199 (73.37%) 
NEUTROPENIA * 1  156/194 (80.41%)  149/199 (74.87%) 
THROMBOCYTOPENIA * 1  92/194 (47.42%)  102/199 (51.26%) 
Gastrointestinal disorders     
ABDOMINAL DISTENSION * 1  21/194 (10.82%)  13/199 (6.53%) 
ABDOMINAL PAIN * 1  37/194 (19.07%)  19/199 (9.55%) 
CONSTIPATION * 1  43/194 (22.16%)  29/199 (14.57%) 
DIARRHOEA * 1  69/194 (35.57%)  35/199 (17.59%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  12/194 (6.19%)  5/199 (2.51%) 
HAEMATOCHEZIA * 1  10/194 (5.15%)  5/199 (2.51%) 
MOUTH ULCERATION * 1  22/194 (11.34%)  9/199 (4.52%) 
NAUSEA * 1  70/194 (36.08%)  92/199 (46.23%) 
STOMATITIS * 1  32/194 (16.49%)  14/199 (7.04%) 
VOMITING * 1  43/194 (22.16%)  52/199 (26.13%) 
General disorders     
FATIGUE * 1  77/194 (39.69%)  56/199 (28.14%) 
PYREXIA * 1  59/194 (30.41%)  48/199 (24.12%) 
ASTHENIA * 1  11/194 (5.67%)  13/199 (6.53%) 
Hepatobiliary disorders     
HYPERBILIRUBINAEMIA * 1  19/194 (9.79%)  21/199 (10.55%) 
LIVER INJURY * 1  12/194 (6.19%)  6/199 (3.02%) 
Immune system disorders     
DRUG HYPERSENSITIVITY * 1  18/194 (9.28%)  15/199 (7.54%) 
Infections and infestations     
NASOPHARYNGITIS * 1  10/194 (5.15%)  4/199 (2.01%) 
PARONYCHIA * 1  28/194 (14.43%)  0/199 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION * 1  18/194 (9.28%)  14/199 (7.04%) 
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION * 1  20/194 (10.31%)  12/199 (6.03%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED * 1  65/194 (33.51%)  54/199 (27.14%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  58/194 (29.90%)  58/199 (29.15%) 
BLOOD ALBUMIN DECREASED * 1  12/194 (6.19%)  4/199 (2.01%) 
BLOOD ALKALINE PHOSPHATASE INCREASED * 1  16/194 (8.25%)  8/199 (4.02%) 
BLOOD BILIRUBIN INCREASED * 1  15/194 (7.73%)  7/199 (3.52%) 
BLOOD LACTATE DEHYDROGENASE INCREASED * 1  11/194 (5.67%)  11/199 (5.53%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED * 1  12/194 (6.19%)  11/199 (5.53%) 
HAEMOGLOBIN DECREASED * 1  28/194 (14.43%)  42/199 (21.11%) 
NEUTROPHIL COUNT DECREASED * 1  11/194 (5.67%)  13/199 (6.53%) 
PLATELET COUNT DECREASED * 1  19/194 (9.79%)  18/199 (9.05%) 
WEIGHT DECREASED * 1  51/194 (26.29%)  26/199 (13.07%) 
WEIGHT INCREASED * 1  23/194 (11.86%)  14/199 (7.04%) 
WHITE BLOOD CELL COUNT DECREASED * 1  14/194 (7.22%)  9/199 (4.52%) 
Metabolism and nutrition disorders     
DECREASED APPETITE * 1  75/194 (38.66%)  60/199 (30.15%) 
HYPERGLYCAEMIA * 1  10/194 (5.15%)  5/199 (2.51%) 
HYPOALBUMINAEMIA * 1  13/194 (6.70%)  13/199 (6.53%) 
HYPOCALCAEMIA * 1  23/194 (11.86%)  14/199 (7.04%) 
HYPONATRAEMIA * 1  16/194 (8.25%)  18/199 (9.05%) 
HYPOPHOSPHATAEMIA * 1  12/194 (6.19%)  4/199 (2.01%) 
HYPOKALAEMIA * 1  65/194 (33.51%)  38/199 (19.10%) 
HYPOMAGNESAEMIA * 1  39/194 (20.10%)  6/199 (3.02%) 
HYPOPROTEINAEMIA * 1  7/194 (3.61%)  11/199 (5.53%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN * 1  11/194 (5.67%)  11/199 (5.53%) 
Nervous system disorders     
HYPOAESTHESIA * 1  25/194 (12.89%)  27/199 (13.57%) 
NEUROTOXICITY * 1  15/194 (7.73%)  18/199 (9.05%) 
Psychiatric disorders     
INSOMNIA * 1  11/194 (5.67%)  10/199 (5.03%) 
INSOMNIA * 1  10/194 (5.15%)  10/199 (5.03%) 
Respiratory, thoracic and mediastinal disorders     
COUGH * 1  18/194 (9.28%)  16/199 (8.04%) 
Skin and subcutaneous tissue disorders     
DERMATITIS ACNEIFORM * 1  31/194 (15.98%)  1/199 (0.50%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME * 1  17/194 (8.76%)  7/199 (3.52%) 
PRURITUS * 1  10/194 (5.15%)  3/199 (1.51%) 
RASH * 1  120/194 (61.86%)  7/199 (3.52%) 
SKIN FISSURES * 1  17/194 (8.76%)  0/199 (0.00%) 
DRY SKIN * 1  11/194 (5.67%)  0/199 (0.00%) 
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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: Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@emdgroup.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01228734    
Other Study ID Numbers: EMR62202-057
First Submitted: September 9, 2010
First Posted: October 26, 2010
Results First Submitted: January 13, 2017
Results First Posted: March 6, 2017
Last Update Posted: January 28, 2020