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ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT01001377
Collaborator
(none)
1,010
Enrollment
152
Locations
2
Arms
85.1
Actual Duration (Months)
6.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1010 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer
Actual Study Start Date :
Feb 2, 2010
Actual Primary Completion Date :
Feb 5, 2013
Actual Study Completion Date :
Mar 7, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cetuximab

Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.

Drug: Cetuximab
Administered by intravenous infusion
Other Names:
  • Erbitux

    		•
    Experimental: Panitumumab

    Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.

    Drug: Panitumumab
    Administered by intravenous infusion
    Other Names:
  • Vectibix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.]

      Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.

    Secondary Outcome Measures

    1. Progression-free Survival [From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.]

      Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.

    2. Objective Response [From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.]

      Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.

    3. Duration of Response [From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.]

      Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.

    4. Time to Response [From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.]

      Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.

    5. Time to Treatment Failure [From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.]

      Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.

    6. Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score [From Study Day 1 through the last day of treatment or disease progression, up to Week 85.]

      The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.

    7. Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS) [From Study Day 1 through the last day of treatment or disease progression, up to Week 85.]

      The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.

    8. Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score [From Study Day 1 through the last day of treatment or disease progression, up to Week 85.]

      The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).

    9. Change From Baseline in NCCN FCSI Physical Well-being Scale Score [From Study Day 1 through the last day of treatment or disease progression, up to Week 85.]

      The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).

    10. Change From Baseline in NCCN FCSI Functional Well-being Scale Score [From Study Day 1 through the last day of treatment or disease progression, up to Week 85.]

      The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).

    11. Number of Participants With Adverse Events (AEs) [From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.]

      Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease

    • Wild-type KRAS tumor status

    • Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2

    • Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease

    • Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)

    • Adequate hematologic, renal, hepatic and metabolic function

    Exclusion Criteria:

    • Symptomatic brain metastases requiring treatment

    • Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)

    • Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization.

    • Clinically significant cardiovascular disease

    • Active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Stockton California United States 95204
    2 Research Site Boynton Beach Florida United States 33426
    3 Research Site Wichita Kansas United States 67214
    4 Research Site Temple Texas United States 76508
    5 Research Site Ogden Utah United States 84403
    6 Research Site Liverpool New South Wales Australia 2170
    7 Research Site St Leonards New South Wales Australia 2065
    8 Research Site Wahroonga New South Wales Australia 2076
    9 Research Site Wollongong New South Wales Australia 2500
    10 Research Site Woodville South South Australia Australia 5011
    11 Research Site Ballarat Victoria Australia 3350
    12 Research Site Box Hill Victoria Australia 3128
    13 Research Site Epping Victoria Australia 3076
    14 Research Site Footscray Victoria Australia 3011
    15 Research Site Heidelberg Victoria Australia 3084
    16 Research Site Parkville Victoria Australia 3050
    17 Research Site Edegem Belgium 2650
    18 Research Site Sofia Bulgaria 1527
    19 Research Site Sofia Bulgaria 1784
    20 Research Site Edmonton Alberta Canada T6G 1Z2
    21 Research Site Halifax Nova Scotia Canada B3H 2Y9
    22 Research Site Guangzhou Guangdong China 510060
    23 Research Site Guangzhou Guangdong China 510180
    24 Research Site Guangzhou Guangdong China 510280
    25 Research Site Guangzhou Guangdong China 515515
    26 Research Site Harbin Heilongjiang China 150040
    27 Research Site Changsha Hunan China 410013
    28 Research Site Nanjing Jiangsu China 210002
    29 Research Site Changchun Jilin China 130012
    30 Research Site XI An Shaanxi China 710061
    31 Research Site Shanghai Shanghai China 200092
    32 Research Site Chengdu Sichuan China 610041
    33 Research Site Chongqing Sichuan China 400038
    34 Research Site Hangzhou Zhejiang China 310009
    35 Research Site Hangzhou Zhejiang China 310016
    36 Research Site Beijing China 100021
    37 Research Site Beijing China 100071
    38 Research Site Beijing China 100142
    39 Research Site Shanghai China 200003
    40 Research Site Shanghai China 200032
    41 Research Site Shanghai China 200080
    42 Research Site Tianjin China 300060
    43 Research Site Horovice Czechia 268 31
    44 Research Site Nova Ves pod Plesi Czechia 262 04
    45 Research Site Olomouc Czechia 775 20
    46 Research Site Praha 10 Czechia 100 34
    47 Research Site Pribram Czechia 261 01
    48 Research Site Znojmo Czechia 669 02
    49 Research Site Besançon Cedex France 25030
    50 Research Site Montbéliard France 25200
    51 Research Site Saint Brieuc France 22015
    52 Research Site Saint Herblain France 44800
    53 Research Site Villejuif cedex France 94805
    54 Research Site Kowloon Hong Kong
    55 Research Site New Territories Hong Kong
    56 Research Site Hyderabad Andhra Pradesh India 500 024
    57 Research Site Hyderabad Andhra Pradesh India 500 034
    58 Research Site Kochi Kerala India 682 304
    59 Research Site Ahmednagar Maharashtra India 413 736
    60 Research Site Nagpur Maharashtra India 440 012
    61 Research Site Nashik Maharashtra India 422 004
    62 Research Site Nashik Maharashtra India 422 005
    63 Research Site Pune Maharashtra India 411 004
    64 Research Site Jaipur Rajasthan India 302 013
    65 Research Site Chennai Tamil Nadu India 600 018
    66 Research Site Kolkata West Bengal India 700 016
    67 Research Site Beer Sheva Israel 64239
    68 Research Site Jerusalem Israel 91031
    69 Research Site Kfar Saba Israel 44281
    70 Research Site Ramat Gan Israel 52621
    71 Research Site Rehovot Israel 76100
    72 Research Site Ancona Italy 60131
    73 Research Site Cesena Italy 47023
    74 Research Site Cremona Italy 26100
    75 Research Site Faenza RA Italy 48018
    76 Research Site Genova Italy 16132
    77 Research Site Lugo Italy 48022
    78 Research Site Meldola FC Italy 47014
    79 Research Site Ravenna Italy 48100
    80 Research Site Rimini Italy 47900
    81 Research Site Torino Italy 10126
    82 Research Site Goyang-si, Gyeonggi-do Korea, Republic of 410-769
    83 Research Site Seoul Korea, Republic of 110-744
    84 Research Site Seoul Korea, Republic of 120-752
    85 Research Site Seoul Korea, Republic of 135-710
    86 Research Site Seoul Korea, Republic of 136-705
    87 Research Site Seoul Korea, Republic of 138-736
    88 Research Site Daugavpils Latvia 5417
    89 Research Site Riga Latvia 1002
    90 Research Site Riga Latvia 1079
    91 Research Site Kaunas Lithuania 50009
    92 Research Site Vilnius Lithuania 08660
    93 Research Site Kota Bharu Kelantan Malaysia 16150
    94 Research Site Kota Kinabalu Sabah Malaysia 88996
    95 Research Site Kuala Lumpur Wilayah Persekutuan Malaysia 56000
    96 Research Site Kuala Lumpur Wilayah Persekutuan Malaysia 59100
    97 Research Site Rotterdam Netherlands 3000 CA
    98 Research Site Lima Peru 13
    99 Research Site Lima Peru 34
    100 Research Site Lima Peru Lima 27
    101 Research Site Cebu City Philippines 6000
    102 Research Site Manila Philippines 1000
    103 Research Site Quezon City Philippines 1102
    104 Research Site Elblag Poland 82-300
    105 Research Site Gdansk Poland 80-219
    106 Research Site Jelenia Gora Poland 58-506
    107 Research Site Poznan Poland 61-485
    108 Research Site Szczecin Poland 71-730
    109 Research Site Warszawa Poland 02-097
    110 Research Site Warszawa Poland 02-507
    111 Research Site Warszawa Poland 02-781
    112 Research Site Bucharest Romania 022328
    113 Research Site Sibiu Romania 550245
    114 Research Site Moscow Russian Federation 115478
    115 Research Site Moscow Russian Federation 117997
    116 Research Site Saint Petersburg Russian Federation 197022
    117 Research Site Saint-Petersburg Russian Federation 197758
    118 Research Site Saint-Petersburg Russian Federation 198255
    119 Research Site Nis Serbia 18000
    120 Research Site Sremska Kamenica Serbia 21204
    121 Research Site Singapore Singapore 119228
    122 Research Site Singapore Singapore 308433
    123 Research Site Bardejov Slovakia 085 01
    124 Research Site Bratislava Slovakia 831 01
    125 Research Site Nitra Slovakia 950 01
    126 Research Site Groenkloof Gauteng South Africa 0181
    127 Research Site Johannesburg Gauteng South Africa 2199
    128 Research Site Kraaifontein Western Cape South Africa 7570
    129 Research Site Johannesburg South Africa 2193
    130 Research Site Port Elizabeth South Africa 6045
    131 Research Site Göteborg Sweden 416 85
    132 Research Site Linköping Sweden 581 85
    133 Research Site Lund Sweden 221 85
    134 Research Site Uppsala Sweden 751 85
    135 Research Site Västerås Sweden 721 89
    136 Research Site Växjö Sweden 351 85
    137 Research Site Putzu City Chiayi Taiwan 61363
    138 Research Site Keelung Taiwan 20401
    139 Research Site Tainan Taiwan 70403
    140 Research Site Taipei Taiwan 11031
    141 Research Site Taoyuan Taiwan 33305
    142 Research Site Belfast United Kingdom BT9 7AB
    143 Research Site Bristol United Kingdom BS2 8ED
    144 Research Site Cardiff United Kingdom CF14 2TL
    145 Research Site Guildford United Kingdom GU2 7XX
    146 Research Site Leicester United Kingdom LE1 5WW
    147 Research Site London United Kingdom SW17 0QT
    148 Research Site Maidstone United Kingdom ME16 9QQ
    149 Research Site Manchester United Kingdom M20 4BX
    150 Research Site Oxford United Kingdom OX3 7LJ
    151 Research Site Sutton United Kingdom SM2 5PT
    152 Research Site Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01001377
    Other Study ID Numbers:
    • 20080763
    • ASPECCT
    • 2009-010715-32
    First Posted:
    Oct 26, 2009
    Last Update Posted:
    Dec 26, 2018
    Last Verified:
    Dec 1, 2018
    Keywords provided by Amgen
    Panitumumab
    Vectibix
    Colon Cancer
    Colorectal Cancer
    Rectal Cancer
    Cetuximab
    Erbitux
    Metastatic
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Cetuximab
    Panitumumab

    Study Results

    Participant Flow

    Recruitment Details First patient enrolled on 2nd February 2010 and last patient enrolled 19 July 2012. Results are reported as of the data cut-off date of 5 February 2013.
    Pre-assignment Detail
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Period Title: Overall Study
    STARTED 504 506
    Received Treatment 500 499
    COMPLETED 78 85
    NOT COMPLETED 426 421

    Baseline Characteristics

    Arm/Group Title Cetuximab Panitumumab Total
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days. Total of all reporting groups
    Overall Participants 504 506 1010
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60.2
    (11.2)
    59.6
    (10.9)
    59.9
    (11.1)
    Sex: Female, Male (Count of Participants)
    Female
    183
    36.3%
    187
    37%
    370
    36.6%
    Male
    321
    63.7%
    319
    63%
    640
    63.4%
    Race/Ethnicity, Customized (participants) [Number]
    Asian
    230
    45.6%
    225
    44.5%
    455
    45%
    Black or African American
    4
    0.8%
    2
    0.4%
    6
    0.6%
    Hispanic or Latino
    7
    1.4%
    6
    1.2%
    13
    1.3%
    Japanese
    0
    0%
    1
    0.2%
    1
    0.1%
    Other
    3
    0.6%
    2
    0.4%
    5
    0.5%
    White or Caucasian
    260
    51.6%
    270
    53.4%
    530
    52.5%
    Geographic region (participants) [Number]
    North America, Western Europe and Australia
    158
    31.3%
    158
    31.2%
    316
    31.3%
    Rest of World
    346
    68.7%
    348
    68.8%
    694
    68.7%
    Eastern Cooperative Oncology Group (ECOG) performance status (participants) [Number]
    Grade 0
    165
    32.7%
    155
    30.6%
    320
    31.7%
    Grade 1
    299
    59.3%
    309
    61.1%
    608
    60.2%
    Grade 2
    40
    7.9%
    42
    8.3%
    82
    8.1%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival
    Description Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
    Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

    Outcome Measure Data

    Analysis Population Description
    Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 500 499
    Median (95% Confidence Interval) [months]
    10.0
    10.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Stratified Cox proportional hazard ratio
    Estimated Value 0.966
    Confidence Interval (2-Sided) 95%
    0.839 to 1.113
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard ratio is presented as panitumumab : cetuximab. A value < 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value < -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.
    Statistical Test of Hypothesis p-Value 0.0007
    Comments A synthesis approach with an asymptotic standard normal test statistic
    Method Asymptotic standard normal test
    Comments
    Method of Estimation Estimation Parameter Normal score
    Estimated Value -3.19
    Confidence Interval () %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Progression-free Survival
    Description Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.
    Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

    Outcome Measure Data

    Analysis Population Description
    Primary analysis set
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 500 499
    Median (95% Confidence Interval) [months]
    4.4
    4.1
    3. Secondary Outcome
    Title Objective Response
    Description Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.
    Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

    Outcome Measure Data

    Analysis Population Description
    Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 485 486
    Number (95% Confidence Interval) [percentage of participants]
    19.79
    3.9%
    22.02
    4.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 1.15
    Confidence Interval (2-Sided) 95%
    0.83 to 1.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).
    4. Secondary Outcome
    Title Duration of Response
    Description Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.
    Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

    Outcome Measure Data

    Analysis Population Description
    Participants with an objective response
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 96 107
    Median (95% Confidence Interval) [months]
    5.4
    3.8
    5. Secondary Outcome
    Title Time to Response
    Description Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.
    Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

    Outcome Measure Data

    Analysis Population Description
    Participants with an objective response
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 96 107
    Median (Inter-Quartile Range) [months]
    2.6
    1.5
    6. Secondary Outcome
    Title Time to Treatment Failure
    Description Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.
    Time Frame From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.

    Outcome Measure Data

    Analysis Population Description
    Primary analysis set
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 500 499
    Median (95% Confidence Interval) [months]
    3.3
    3.4
    7. Secondary Outcome
    Title Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score
    Description The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.
    Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 150 143
    Least Squares Mean (95% Confidence Interval) [scores on a scale]
    -0.0341
    -0.0216
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.0126
    Confidence Interval (2-Sided) 95%
    -0.0353 to 0.0605
    Parameter Dispersion Type:
    Value:
    Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
    8. Secondary Outcome
    Title Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)
    Description The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.
    Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) analysis set participants with available data
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 149 142
    Least Squares Mean (95% Confidence Interval) [scores on a scale]
    3.9782
    2.3037
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.6745
    Confidence Interval (2-Sided) 95%
    -4.9331 to 1.5841
    Parameter Dispersion Type:
    Value:
    Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
    9. Secondary Outcome
    Title Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score
    Description The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
    Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) analysis set participants with available data.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 151 142
    Least Squares Mean (95% Confidence Interval) [scores on a scale]
    2.0101
    3.0473
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.0372
    Confidence Interval (2-Sided) 95%
    -2.3267 to 4.4010
    Parameter Dispersion Type:
    Value:
    Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
    10. Secondary Outcome
    Title Change From Baseline in NCCN FCSI Physical Well-being Scale Score
    Description The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
    Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) analysis set participants with available data.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 150 142
    Least Squares Mean (95% Confidence Interval) [scores on a scale]
    1.8778
    2.4614
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.5836
    Confidence Interval (2-Sided) 95%
    -3.0269 to 4.1941
    Parameter Dispersion Type:
    Value:
    Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
    11. Secondary Outcome
    Title Change From Baseline in NCCN FCSI Functional Well-being Scale Score
    Description The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
    Time Frame From Study Day 1 through the last day of treatment or disease progression, up to Week 85.

    Outcome Measure Data

    Analysis Population Description
    Patient reported outcomes (PRO) analysis set participants with available data.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 152 143
    Least Squares Mean (95% Confidence Interval) [scores on a scale]
    1.3567
    1.1569
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cetuximab, Panitumumab
    Comments Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.1998
    Confidence Interval (2-Sided) 95%
    -6.0093 to 5.6098
    Parameter Dispersion Type:
    Value:
    Estimation Comments A positive difference between the treatment groups favors the panitumumab group.
    12. Secondary Outcome
    Title Number of Participants With Adverse Events (AEs)
    Description Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.
    Time Frame From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    Measure Participants 503 496
    Any adverse event (AE)
    494
    98%
    485
    95.8%
    Serious adverse events
    169
    33.5%
    151
    29.8%
    Leading to discontinuation of study drug
    61
    12.1%
    69
    13.6%
    Any treatment-related adverse event (TRAE)
    459
    91.1%
    437
    86.4%
    Treatment-related serious adverse event
    22
    4.4%
    25
    4.9%
    TRAE leading to discontinuation of study drug
    15
    3%
    14
    2.8%

    Adverse Events

    Time Frame Median time was 117 days for panitumumab arm and 123 days for cetuximab arm.
    Adverse Event Reporting Description Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
    Arm/Group Title Cetuximab Panitumumab
    Arm/Group Description Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days. Panitumumab 6 mg/kg IV every 14 days.
    All Cause Mortality
    Cetuximab Panitumumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Cetuximab Panitumumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 169/503 (33.6%) 151/496 (30.4%)
    Blood and lymphatic system disorders
    Anaemia 3/503 (0.6%) 6/496 (1.2%)
    Disseminated intravascular coagulation 0/503 (0%) 1/496 (0.2%)
    Cardiac disorders
    Atrial fibrillation 1/503 (0.2%) 1/496 (0.2%)
    Cardiac arrest 0/503 (0%) 1/496 (0.2%)
    Cardiac failure congestive 1/503 (0.2%) 0/496 (0%)
    Cardiomyopathy 1/503 (0.2%) 0/496 (0%)
    Cardiopulmonary failure 1/503 (0.2%) 0/496 (0%)
    Cardiovascular insufficiency 1/503 (0.2%) 0/496 (0%)
    Myocardial infarction 0/503 (0%) 1/496 (0.2%)
    Myocardial ischaemia 1/503 (0.2%) 0/496 (0%)
    Tachycardia 0/503 (0%) 1/496 (0.2%)
    Gastrointestinal disorders
    Abdominal distension 4/503 (0.8%) 0/496 (0%)
    Abdominal mass 1/503 (0.2%) 0/496 (0%)
    Abdominal pain 13/503 (2.6%) 10/496 (2%)
    Abdominal pain lower 1/503 (0.2%) 0/496 (0%)
    Abdominal pain upper 2/503 (0.4%) 3/496 (0.6%)
    Ascites 5/503 (1%) 5/496 (1%)
    Colitis 2/503 (0.4%) 0/496 (0%)
    Constipation 3/503 (0.6%) 2/496 (0.4%)
    Diarrhoea 8/503 (1.6%) 6/496 (1.2%)
    Duodenal obstruction 1/503 (0.2%) 0/496 (0%)
    Duodenal ulcer 1/503 (0.2%) 0/496 (0%)
    Dyspepsia 1/503 (0.2%) 0/496 (0%)
    Dysphagia 0/503 (0%) 1/496 (0.2%)
    Enteritis 0/503 (0%) 1/496 (0.2%)
    Faecaloma 0/503 (0%) 1/496 (0.2%)
    Gastritis 1/503 (0.2%) 1/496 (0.2%)
    Gastrointestinal haemorrhage 1/503 (0.2%) 2/496 (0.4%)
    Gastrointestinal obstruction 0/503 (0%) 1/496 (0.2%)
    Gastrooesophageal reflux disease 1/503 (0.2%) 0/496 (0%)
    Haematochezia 1/503 (0.2%) 0/496 (0%)
    Ileus 5/503 (1%) 5/496 (1%)
    Intestinal infarction 0/503 (0%) 1/496 (0.2%)
    Intestinal obstruction 8/503 (1.6%) 12/496 (2.4%)
    Intestinal perforation 0/503 (0%) 1/496 (0.2%)
    Large intestinal obstruction 0/503 (0%) 1/496 (0.2%)
    Large intestine perforation 0/503 (0%) 2/496 (0.4%)
    Lower gastrointestinal haemorrhage 1/503 (0.2%) 0/496 (0%)
    Melaena 1/503 (0.2%) 0/496 (0%)
    Mesenteric vein thrombosis 0/503 (0%) 1/496 (0.2%)
    Nausea 5/503 (1%) 2/496 (0.4%)
    Obturator hernia 0/503 (0%) 1/496 (0.2%)
    Pancreatitis acute 1/503 (0.2%) 0/496 (0%)
    Peritoneal adhesions 1/503 (0.2%) 0/496 (0%)
    Proctalgia 0/503 (0%) 1/496 (0.2%)
    Rectal haemorrhage 0/503 (0%) 1/496 (0.2%)
    Rectal polyp 1/503 (0.2%) 0/496 (0%)
    Rectal tenesmus 0/503 (0%) 1/496 (0.2%)
    Small intestinal obstruction 3/503 (0.6%) 4/496 (0.8%)
    Small intestinal perforation 1/503 (0.2%) 0/496 (0%)
    Stomatitis 0/503 (0%) 1/496 (0.2%)
    Subileus 1/503 (0.2%) 2/496 (0.4%)
    Vomiting 5/503 (1%) 12/496 (2.4%)
    General disorders
    Asthenia 4/503 (0.8%) 6/496 (1.2%)
    Chest discomfort 1/503 (0.2%) 1/496 (0.2%)
    Chest pain 0/503 (0%) 1/496 (0.2%)
    Death 1/503 (0.2%) 0/496 (0%)
    Device occlusion 0/503 (0%) 2/496 (0.4%)
    Fatigue 4/503 (0.8%) 4/496 (0.8%)
    Gait disturbance 0/503 (0%) 1/496 (0.2%)
    General physical health deterioration 2/503 (0.4%) 1/496 (0.2%)
    Hyperpyrexia 0/503 (0%) 1/496 (0.2%)
    Malaise 0/503 (0%) 1/496 (0.2%)
    Multi-organ failure 1/503 (0.2%) 0/496 (0%)
    Non-cardiac chest pain 0/503 (0%) 1/496 (0.2%)
    Oedema 1/503 (0.2%) 0/496 (0%)
    Oedema peripheral 2/503 (0.4%) 1/496 (0.2%)
    Pain 1/503 (0.2%) 0/496 (0%)
    Performance status decreased 1/503 (0.2%) 1/496 (0.2%)
    Pyrexia 8/503 (1.6%) 3/496 (0.6%)
    Systemic inflammatory response syndrome 0/503 (0%) 1/496 (0.2%)
    Hepatobiliary disorders
    Bile duct obstruction 2/503 (0.4%) 1/496 (0.2%)
    Cholangitis 0/503 (0%) 1/496 (0.2%)
    Cholecystitis 1/503 (0.2%) 0/496 (0%)
    Cholestasis 0/503 (0%) 1/496 (0.2%)
    Hepatic failure 2/503 (0.4%) 1/496 (0.2%)
    Hepatic function abnormal 4/503 (0.8%) 2/496 (0.4%)
    Hepatic lesion 1/503 (0.2%) 0/496 (0%)
    Hepatocellular injury 0/503 (0%) 1/496 (0.2%)
    Hyperbilirubinaemia 4/503 (0.8%) 1/496 (0.2%)
    Jaundice 0/503 (0%) 3/496 (0.6%)
    Jaundice cholestatic 2/503 (0.4%) 0/496 (0%)
    Jaundice extrahepatic obstructive 1/503 (0.2%) 0/496 (0%)
    Immune system disorders
    Anaphylactic reaction 3/503 (0.6%) 0/496 (0%)
    Cytokine release syndrome 1/503 (0.2%) 0/496 (0%)
    Hypersensitivity 2/503 (0.4%) 1/496 (0.2%)
    Infections and infestations
    Abdominal abscess 1/503 (0.2%) 0/496 (0%)
    Abscess limb 1/503 (0.2%) 0/496 (0%)
    Anal abscess 0/503 (0%) 1/496 (0.2%)
    Bacteraemia 1/503 (0.2%) 0/496 (0%)
    Bronchopneumonia 1/503 (0.2%) 0/496 (0%)
    Cellulitis 1/503 (0.2%) 2/496 (0.4%)
    Cystitis 0/503 (0%) 1/496 (0.2%)
    Device related infection 1/503 (0.2%) 2/496 (0.4%)
    Device related sepsis 1/503 (0.2%) 0/496 (0%)
    Enterococcal infection 1/503 (0.2%) 0/496 (0%)
    Escherichia infection 1/503 (0.2%) 0/496 (0%)
    Furuncle 1/503 (0.2%) 0/496 (0%)
    Gastroenteritis 1/503 (0.2%) 1/496 (0.2%)
    Gastroenteritis viral 0/503 (0%) 1/496 (0.2%)
    Gastrointestinal infection 1/503 (0.2%) 1/496 (0.2%)
    Herpes zoster 1/503 (0.2%) 0/496 (0%)
    Infected dermal cyst 0/503 (0%) 1/496 (0.2%)
    Infection 1/503 (0.2%) 2/496 (0.4%)
    Lobar pneumonia 0/503 (0%) 1/496 (0.2%)
    Lower respiratory tract infection 2/503 (0.4%) 0/496 (0%)
    Lung infection 2/503 (0.4%) 0/496 (0%)
    Nail infection 0/503 (0%) 1/496 (0.2%)
    Neutropenic sepsis 1/503 (0.2%) 0/496 (0%)
    Paronychia 1/503 (0.2%) 0/496 (0%)
    Peritonitis 0/503 (0%) 1/496 (0.2%)
    Pneumonia 7/503 (1.4%) 2/496 (0.4%)
    Pyelonephritis acute 1/503 (0.2%) 1/496 (0.2%)
    Pyonephrosis 1/503 (0.2%) 0/496 (0%)
    Respiratory tract infection 0/503 (0%) 1/496 (0.2%)
    Sepsis 1/503 (0.2%) 5/496 (1%)
    Septic shock 1/503 (0.2%) 0/496 (0%)
    Staphylococcal sepsis 1/503 (0.2%) 0/496 (0%)
    Subcutaneous abscess 0/503 (0%) 1/496 (0.2%)
    Tooth abscess 0/503 (0%) 1/496 (0.2%)
    Upper respiratory tract infection 0/503 (0%) 1/496 (0.2%)
    Urinary bladder abscess 1/503 (0.2%) 0/496 (0%)
    Urinary tract infection 7/503 (1.4%) 9/496 (1.8%)
    Urosepsis 0/503 (0%) 1/496 (0.2%)
    Injury, poisoning and procedural complications
    Cervical vertebral fracture 0/503 (0%) 1/496 (0.2%)
    Contusion 0/503 (0%) 1/496 (0.2%)
    Fall 0/503 (0%) 1/496 (0.2%)
    Fracture 0/503 (0%) 1/496 (0.2%)
    Joint dislocation 1/503 (0.2%) 0/496 (0%)
    Laceration 0/503 (0%) 1/496 (0.2%)
    Poisoning 1/503 (0.2%) 0/496 (0%)
    Scapula fracture 0/503 (0%) 1/496 (0.2%)
    Soft tissue injury 0/503 (0%) 1/496 (0.2%)
    Wound complication 1/503 (0.2%) 0/496 (0%)
    Investigations
    Blood bilirubin increased 2/503 (0.4%) 2/496 (0.4%)
    Blood creatine increased 0/503 (0%) 1/496 (0.2%)
    Blood creatinine increased 1/503 (0.2%) 1/496 (0.2%)
    Blood uric acid increased 0/503 (0%) 1/496 (0.2%)
    Haemoglobin decreased 0/503 (0%) 2/496 (0.4%)
    Red blood cell count decreased 0/503 (0%) 1/496 (0.2%)
    Metabolism and nutrition disorders
    Decreased appetite 3/503 (0.6%) 0/496 (0%)
    Dehydration 0/503 (0%) 2/496 (0.4%)
    Diabetes mellitus 1/503 (0.2%) 1/496 (0.2%)
    Diabetes mellitus inadequate control 1/503 (0.2%) 0/496 (0%)
    Fluid overload 1/503 (0.2%) 0/496 (0%)
    Hypercalcaemia 1/503 (0.2%) 1/496 (0.2%)
    Hyperkalaemia 0/503 (0%) 4/496 (0.8%)
    Hyperuricaemia 1/503 (0.2%) 0/496 (0%)
    Hypoalbuminaemia 1/503 (0.2%) 0/496 (0%)
    Hypoglycaemia 1/503 (0.2%) 0/496 (0%)
    Hypokalaemia 0/503 (0%) 1/496 (0.2%)
    Hypomagnesaemia 1/503 (0.2%) 3/496 (0.6%)
    Hyponatraemia 0/503 (0%) 2/496 (0.4%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/503 (0.2%) 0/496 (0%)
    Back pain 2/503 (0.4%) 4/496 (0.8%)
    Flank pain 0/503 (0%) 1/496 (0.2%)
    Groin pain 0/503 (0%) 1/496 (0.2%)
    Muscle haemorrhage 1/503 (0.2%) 0/496 (0%)
    Muscular weakness 1/503 (0.2%) 1/496 (0.2%)
    Musculoskeletal chest pain 0/503 (0%) 1/496 (0.2%)
    Musculoskeletal pain 0/503 (0%) 1/496 (0.2%)
    Pain in extremity 0/503 (0%) 1/496 (0.2%)
    Pathological fracture 1/503 (0.2%) 0/496 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer 5/503 (1%) 5/496 (1%)
    Colon cancer metastatic 6/503 (1.2%) 4/496 (0.8%)
    Colorectal cancer 10/503 (2%) 7/496 (1.4%)
    Colorectal cancer metastatic 14/503 (2.8%) 7/496 (1.4%)
    Infected neoplasm 0/503 (0%) 1/496 (0.2%)
    Metastases to bone 0/503 (0%) 2/496 (0.4%)
    Metastases to central nervous system 2/503 (0.4%) 4/496 (0.8%)
    Metastases to liver 2/503 (0.4%) 0/496 (0%)
    Metastases to meninges 1/503 (0.2%) 0/496 (0%)
    Metastases to ovary 1/503 (0.2%) 0/496 (0%)
    Metastases to spine 0/503 (0%) 1/496 (0.2%)
    Rectal cancer 2/503 (0.4%) 1/496 (0.2%)
    Tumour haemorrhage 1/503 (0.2%) 0/496 (0%)
    Tumour necrosis 0/503 (0%) 2/496 (0.4%)
    Tumour pain 0/503 (0%) 1/496 (0.2%)
    Tumour thrombosis 0/503 (0%) 1/496 (0.2%)
    Nervous system disorders
    Altered state of consciousness 0/503 (0%) 1/496 (0.2%)
    Carotid artery stenosis 1/503 (0.2%) 0/496 (0%)
    Central nervous system lesion 1/503 (0.2%) 0/496 (0%)
    Cerebral infarction 2/503 (0.4%) 0/496 (0%)
    Cognitive disorder 0/503 (0%) 1/496 (0.2%)
    Convulsion 1/503 (0.2%) 0/496 (0%)
    Dizziness 0/503 (0%) 1/496 (0.2%)
    Dyskinesia 1/503 (0.2%) 0/496 (0%)
    Hemiparesis 0/503 (0%) 1/496 (0.2%)
    Loss of consciousness 1/503 (0.2%) 0/496 (0%)
    Spinal cord compression 1/503 (0.2%) 0/496 (0%)
    Syncope 0/503 (0%) 2/496 (0.4%)
    Psychiatric disorders
    Anxiety 0/503 (0%) 1/496 (0.2%)
    Confusional state 1/503 (0.2%) 2/496 (0.4%)
    Depression 0/503 (0%) 1/496 (0.2%)
    Renal and urinary disorders
    Azotaemia 2/503 (0.4%) 0/496 (0%)
    Bladder dilatation 0/503 (0%) 1/496 (0.2%)
    Dysuria 1/503 (0.2%) 1/496 (0.2%)
    Haematuria 1/503 (0.2%) 1/496 (0.2%)
    Hydronephrosis 2/503 (0.4%) 4/496 (0.8%)
    Obstructive uropathy 1/503 (0.2%) 0/496 (0%)
    Oliguria 0/503 (0%) 1/496 (0.2%)
    Renal failure 1/503 (0.2%) 2/496 (0.4%)
    Renal failure acute 1/503 (0.2%) 2/496 (0.4%)
    Renal failure chronic 0/503 (0%) 1/496 (0.2%)
    Renal impairment 1/503 (0.2%) 2/496 (0.4%)
    Ureteric stenosis 1/503 (0.2%) 1/496 (0.2%)
    Urinary tract obstruction 0/503 (0%) 1/496 (0.2%)
    Reproductive system and breast disorders
    Female genital tract fistula 1/503 (0.2%) 0/496 (0%)
    Oedema genital 0/503 (0%) 1/496 (0.2%)
    Pelvic pain 0/503 (0%) 1/496 (0.2%)
    Perineal pain 0/503 (0%) 1/496 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/503 (0%) 1/496 (0.2%)
    Asthma 0/503 (0%) 1/496 (0.2%)
    Dyspnoea 6/503 (1.2%) 3/496 (0.6%)
    Epistaxis 1/503 (0.2%) 0/496 (0%)
    Pleural effusion 3/503 (0.6%) 1/496 (0.2%)
    Pleuritic pain 0/503 (0%) 1/496 (0.2%)
    Pneumonia aspiration 0/503 (0%) 1/496 (0.2%)
    Pneumothorax 0/503 (0%) 1/496 (0.2%)
    Productive cough 0/503 (0%) 1/496 (0.2%)
    Pulmonary embolism 1/503 (0.2%) 2/496 (0.4%)
    Respiratory depression 0/503 (0%) 1/496 (0.2%)
    Respiratory distress 1/503 (0.2%) 0/496 (0%)
    Respiratory failure 3/503 (0.6%) 0/496 (0%)
    Skin and subcutaneous tissue disorders
    Skin ulcer 0/503 (0%) 1/496 (0.2%)
    Surgical and medical procedures
    Central venous catheterisation 0/503 (0%) 1/496 (0.2%)
    Salpingo-oophorectomy bilateral 0/503 (0%) 1/496 (0.2%)
    Vascular disorders
    Artery dissection 0/503 (0%) 1/496 (0.2%)
    Deep vein thrombosis 1/503 (0.2%) 1/496 (0.2%)
    Embolism 0/503 (0%) 1/496 (0.2%)
    Haemorrhage 0/503 (0%) 1/496 (0.2%)
    Lymphocele 1/503 (0.2%) 0/496 (0%)
    Superior vena cava syndrome 2/503 (0.4%) 0/496 (0%)
    Thrombosis 0/503 (0%) 1/496 (0.2%)
    Other (Not Including Serious) Adverse Events
    Cetuximab Panitumumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 474/503 (94.2%) 459/496 (92.5%)
    Blood and lymphatic system disorders
    Anaemia 30/503 (6%) 29/496 (5.8%)
    Gastrointestinal disorders
    Abdominal pain 74/503 (14.7%) 52/496 (10.5%)
    Constipation 70/503 (13.9%) 39/496 (7.9%)
    Diarrhoea 87/503 (17.3%) 88/496 (17.7%)
    Dyspepsia 26/503 (5.2%) 19/496 (3.8%)
    Nausea 56/503 (11.1%) 66/496 (13.3%)
    Stomatitis 34/503 (6.8%) 26/496 (5.2%)
    Vomiting 49/503 (9.7%) 49/496 (9.9%)
    General disorders
    Asthenia 44/503 (8.7%) 30/496 (6%)
    Fatigue 85/503 (16.9%) 72/496 (14.5%)
    Oedema peripheral 38/503 (7.6%) 22/496 (4.4%)
    Pyrexia 50/503 (9.9%) 28/496 (5.6%)
    Infections and infestations
    Paronychia 75/503 (14.9%) 58/496 (11.7%)
    Upper respiratory tract infection 28/503 (5.6%) 14/496 (2.8%)
    Investigations
    Weight decreased 21/503 (4.2%) 26/496 (5.2%)
    Metabolism and nutrition disorders
    Decreased appetite 77/503 (15.3%) 69/496 (13.9%)
    Hypocalcaemia 16/503 (3.2%) 26/496 (5.2%)
    Hypokalaemia 23/503 (4.6%) 41/496 (8.3%)
    Hypomagnesaemia 89/503 (17.7%) 134/496 (27%)
    Musculoskeletal and connective tissue disorders
    Back pain 37/503 (7.4%) 34/496 (6.9%)
    Nervous system disorders
    Headache 36/503 (7.2%) 17/496 (3.4%)
    Psychiatric disorders
    Insomnia 46/503 (9.1%) 27/496 (5.4%)
    Respiratory, thoracic and mediastinal disorders
    Cough 38/503 (7.6%) 40/496 (8.1%)
    Dyspnoea 33/503 (6.6%) 19/496 (3.8%)
    Skin and subcutaneous tissue disorders
    Acne 69/503 (13.7%) 52/496 (10.5%)
    Dermatitis acneiform 136/503 (27%) 138/496 (27.8%)
    Dry skin 79/503 (15.7%) 83/496 (16.7%)
    Nail disorder 31/503 (6.2%) 26/496 (5.2%)
    Pruritus 88/503 (17.5%) 83/496 (16.7%)
    Rash 257/503 (51.1%) 249/496 (50.2%)
    Skin fissures 43/503 (8.5%) 42/496 (8.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

    Results Point of Contact

    Name/Title Study Director
    Organization Amgen Inc.
    Phone 866-572-6436
    Email
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT01001377
    Other Study ID Numbers:
    • 20080763
    • ASPECCT
    • 2009-010715-32
    First Posted:
    Oct 26, 2009
    Last Update Posted:
    Dec 26, 2018
    Last Verified:
    Dec 1, 2018