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Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer (SPECTRUM)

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ClinicalTrials.gov Identifier: NCT00460265
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : June 14, 2011
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent and/or Metastatic Head and Neck Cancer
Interventions Drug: ARM 2
Drug: ARM 1
Enrollment 658

Recruitment Details Subjects were enrolled from 25 May 2007 to 10 March 2009.
Pre-assignment Details  
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description Consists of Panitumumab plus Cisplatin and 5-FU Consists of Cisplatin and 5-FU
Period Title: Overall Study
Started 328 330
Randomized While Alive 327 [1] 330
Received Study Medication 325 325
Completed 243 [2] 241 [2]
Not Completed 85 89
Reason Not Completed
Lost to Follow-up             14             15
Physician Decision             1             2
Withdrawal by Subject             10             25
Ongoing             60             47
[1]
1 subject was randomized by error after death
[2]
Completed study=death
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone Total
Hide Arm/Group Description Consists of Panitumumab plus Cisplatin and 5-FU Consists of Cisplatin and 5-FU Total of all reporting groups
Overall Number of Baseline Participants 327 330 657
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 327 participants 330 participants 657 participants
57.6  (8.5) 58.6  (7.8) 58.1  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 327 participants 330 participants 657 participants
Female
44
  13.5%
43
  13.0%
87
  13.2%
Male
283
  86.5%
287
  87.0%
570
  86.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 327 participants 330 participants 657 participants
White or Caucasian 268 271 539
Black or African American 4 2 6
Hispanic or Latino 13 12 25
Asian 25 30 55
Japanese 13 7 20
Aborigine 1 0 1
Other 3 6 9
Unknown/Missing 0 2 2
Previously treated with chemotherapy and/or radiotherapy, Yes/No  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 327 participants 330 participants 657 participants
Yes 267 263 530
No 60 67 127
ECOG perfomance score, 0/1/2  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 327 participants 330 participants 657 participants
0 98 98 196
1 227 228 455
2 2 4 6
Primary tumor site, oropharynx&larynx/oral cavity&hypopharynx  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 327 participants 330 participants 657 participants
Oropharynx and larynx 186 191 377
Oral cavity and hypopharynx 141 139 280
1.Primary Outcome
Title Overall Survival
Hide Description Time from randomization to death
Time Frame Upto 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description:
Consists of Panitumumab plus Cisplatin and 5-FU
Consists of Cisplatin and 5-FU
Overall Number of Participants Analyzed 327 330
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(9.8 to 12.2)
9.0
(8.1 to 11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus Chemotherapy, Chemotherapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1403
Comments [Not Specified]
Method Log Rank
Comments Stratified by IVRS randomization factors (ECOG(0:1),previously treated w/ CT/RT(yes:no),primary tumor site(oropharynx/larynx:oral cavity/hypopharynx))
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.873
Confidence Interval 95%
0.729 to 1.046
Estimation Comments Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone.
2.Secondary Outcome
Title Overall Response Rate
Hide Description An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.
Time Frame Every 6 weeks until disease progression, up to 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The subset of subjects in the ITT analysis set with at least one baseline uni-dimensionally measurable lesion using a modified version of the RECIST v1.0 (see protocol Appendix H)
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description:
Consists of Panitumumab plus Cisplatin and 5-FU
Consists of Cisplatin and 5-FU
Overall Number of Participants Analyzed 278 288
Measure Type: Number
Unit of Measure: subjects
101 73
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus Chemotherapy, Chemotherapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 10.98
Confidence Interval 95%
3.13 to 18.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus Chemotherapy, Chemotherapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.69
Confidence Interval 95%
1.15 to 2.44
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Duration of Response
Hide Description Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).
Time Frame Every 6 weeks until disease progression, up to 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Included only those subjects with a confirmed complete or partial response.
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description:
Consists of Panitumumab plus Cisplatin and 5-FU
Consists of Cisplatin and 5-FU
Overall Number of Participants Analyzed 101 73
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(4.8 to 6.2)
5.7
(4.7 to 6.2)
4.Secondary Outcome
Title Time to Progression
Hide Description Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)
Time Frame Every 6 weeks until disease progression, up to 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description:
Consists of Panitumumab plus Cisplatin and 5-FU
Consists of Cisplatin and 5-FU
Overall Number of Participants Analyzed 327 330
Median (95% Confidence Interval)
Unit of Measure: months
6.8
(5.9 to 6.9)
5.6
(5.2 to 5.8)
5.Secondary Outcome
Title Time to Response
Hide Description Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.
Time Frame Every 6 weeks until disease progression, upto 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Included only those subjects with a confirmed complete response or partial response.
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description:
Consists of Panitumumab plus Cisplatin and 5-FU
Consists of Cisplatin and 5-FU
Overall Number of Participants Analyzed 101 73
Median (Inter-Quartile Range)
Unit of Measure: months
1.4
(1.3 to 2.5)
1.5
(1.3 to 2.6)
6.Secondary Outcome
Title Progression Free Survival
Hide Description Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.
Time Frame Every 6 weeks until disease progression or deaths, upto 56 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description:
Consists of Panitumumab plus Cisplatin and 5-FU
Consists of Cisplatin and 5-FU
Overall Number of Participants Analyzed 327 330
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(5.6 to 6.6)
4.6
(4.1 to 5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab Plus Chemotherapy, Chemotherapy Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.780
Confidence Interval 95%
0.659 to 0.922
Estimation Comments Cox proportional hazards model stratified by IVRS randomization factors
Time Frame The day of the first dose of study therapy through 33 days since the last dose date (up to 56 months)
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Panitumumab Plus Chemotherapy Chemotherapy Alone
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Panitumumab Plus Chemotherapy Chemotherapy Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panitumumab Plus Chemotherapy Chemotherapy Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   157/325 (48.31%)   139/325 (42.77%) 
Blood and lymphatic system disorders     
Anaemia  1  15/325 (4.62%)  16/325 (4.92%) 
Febrile bone marrow aplasia  1  1/325 (0.31%)  0/325 (0.00%) 
Febrile neutropenia  1  18/325 (5.54%)  12/325 (3.69%) 
Haematotoxicity  1  0/325 (0.00%)  1/325 (0.31%) 
Leukopenia  1  3/325 (0.92%)  4/325 (1.23%) 
Lymphadenopathy  1  1/325 (0.31%)  0/325 (0.00%) 
Neutropenia  1  11/325 (3.38%)  14/325 (4.31%) 
Pancytopenia  1  3/325 (0.92%)  0/325 (0.00%) 
Thrombocytopenia  1  8/325 (2.46%)  4/325 (1.23%) 
Cardiac disorders     
Acute myocardial infarction  1  1/325 (0.31%)  0/325 (0.00%) 
Arrhythmia supraventricular  1  1/325 (0.31%)  0/325 (0.00%) 
Atrial fibrillation  1  1/325 (0.31%)  0/325 (0.00%) 
Bradycardia  1  2/325 (0.62%)  0/325 (0.00%) 
Cardiac arrest  1  0/325 (0.00%)  4/325 (1.23%) 
Cardiac failure  1  3/325 (0.92%)  0/325 (0.00%) 
Cardiac failure acute  1  1/325 (0.31%)  0/325 (0.00%) 
Cardio-respiratory arrest  1  1/325 (0.31%)  5/325 (1.54%) 
Cardiopulmonary failure  1  2/325 (0.62%)  1/325 (0.31%) 
Cardiovascular insufficiency  1  0/325 (0.00%)  1/325 (0.31%) 
Intracardiac thrombus  1  1/325 (0.31%)  0/325 (0.00%) 
Myocardial infarction  1  1/325 (0.31%)  0/325 (0.00%) 
Sinus arrhythmia  1  1/325 (0.31%)  0/325 (0.00%) 
Tachycardia  1  1/325 (0.31%)  0/325 (0.00%) 
Congenital, familial and genetic disorders     
Ichthyosis  1  1/325 (0.31%)  0/325 (0.00%) 
Ear and labyrinth disorders     
Hypoacusis  1  1/325 (0.31%)  0/325 (0.00%) 
Vertigo  1  0/325 (0.00%)  2/325 (0.62%) 
Eye disorders     
Papilloedema  1  0/325 (0.00%)  1/325 (0.31%) 
Retinal artery occlusion  1  1/325 (0.31%)  0/325 (0.00%) 
Vision blurred  1  0/325 (0.00%)  1/325 (0.31%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/325 (0.00%)  1/325 (0.31%) 
Aphagia  1  1/325 (0.31%)  0/325 (0.00%) 
Ascites  1  0/325 (0.00%)  1/325 (0.31%) 
Constipation  1  1/325 (0.31%)  0/325 (0.00%) 
Diarrhoea  1  9/325 (2.77%)  4/325 (1.23%) 
Diarrhoea haemorrhagic  1  1/325 (0.31%)  0/325 (0.00%) 
Duodenal ulcer  1  1/325 (0.31%)  0/325 (0.00%) 
Dysphagia  1  3/325 (0.92%)  7/325 (2.15%) 
Faecaloma  1  1/325 (0.31%)  0/325 (0.00%) 
Gastrointestinal haemorrhage  1  1/325 (0.31%)  0/325 (0.00%) 
Gastrointestinal perforation  1  0/325 (0.00%)  1/325 (0.31%) 
Gastrointestinal toxicity  1  0/325 (0.00%)  1/325 (0.31%) 
Haematemesis  1  1/325 (0.31%)  2/325 (0.62%) 
Ileus paralytic  1  1/325 (0.31%)  0/325 (0.00%) 
Inguinal hernia, obstructive  1  1/325 (0.31%)  0/325 (0.00%) 
Melaena  1  1/325 (0.31%)  0/325 (0.00%) 
Mouth haemorrhage  1  1/325 (0.31%)  0/325 (0.00%) 
Nausea  1  12/325 (3.69%)  6/325 (1.85%) 
Necrotising colitis  1  1/325 (0.31%)  0/325 (0.00%) 
Oesophagitis  1  2/325 (0.62%)  0/325 (0.00%) 
Stomatitis  1  3/325 (0.92%)  4/325 (1.23%) 
Upper gastrointestinal haemorrhage  1  1/325 (0.31%)  0/325 (0.00%) 
Vomiting  1  10/325 (3.08%)  8/325 (2.46%) 
General disorders     
Abasia  1  0/325 (0.00%)  1/325 (0.31%) 
Asthenia  1  8/325 (2.46%)  3/325 (0.92%) 
Chest pain  1  1/325 (0.31%)  1/325 (0.31%) 
Death  1  2/325 (0.62%)  2/325 (0.62%) 
Device occlusion  1  1/325 (0.31%)  0/325 (0.00%) 
Face oedema  1  1/325 (0.31%)  0/325 (0.00%) 
Facial pain  1  1/325 (0.31%)  0/325 (0.00%) 
Fatigue  1  4/325 (1.23%)  1/325 (0.31%) 
General physical health deterioration  1  10/325 (3.08%)  9/325 (2.77%) 
Hyperpyrexia  1  1/325 (0.31%)  0/325 (0.00%) 
Hyperthermia  1  1/325 (0.31%)  0/325 (0.00%) 
Infusion site extravasation  1  0/325 (0.00%)  1/325 (0.31%) 
Malaise  1  1/325 (0.31%)  0/325 (0.00%) 
Medical device complication  1  0/325 (0.00%)  2/325 (0.62%) 
Mucosal inflammation  1  5/325 (1.54%)  7/325 (2.15%) 
Multi-organ failure  1  1/325 (0.31%)  0/325 (0.00%) 
Non-cardiac chest pain  1  1/325 (0.31%)  0/325 (0.00%) 
Pain  1  5/325 (1.54%)  0/325 (0.00%) 
Pyrexia  1  5/325 (1.54%)  10/325 (3.08%) 
Sudden death  1  1/325 (0.31%)  2/325 (0.62%) 
Thrombosis in device  1  1/325 (0.31%)  0/325 (0.00%) 
Hepatobiliary disorders     
Hepatic failure  1  1/325 (0.31%)  0/325 (0.00%) 
Jaundice  1  1/325 (0.31%)  0/325 (0.00%) 
Immune system disorders     
Anaphylactic shock  1  1/325 (0.31%)  0/325 (0.00%) 
Hypersensitivity  1  2/325 (0.62%)  0/325 (0.00%) 
Infections and infestations     
Abscess  1  2/325 (0.62%)  0/325 (0.00%) 
Abscess neck  1  1/325 (0.31%)  0/325 (0.00%) 
Aspergillosis  1  1/325 (0.31%)  0/325 (0.00%) 
Bronchiectasis  1  1/325 (0.31%)  0/325 (0.00%) 
Bronchitis  1  1/325 (0.31%)  1/325 (0.31%) 
Bronchopneumonia  1  0/325 (0.00%)  2/325 (0.62%) 
Campylobacter infection  1  1/325 (0.31%)  0/325 (0.00%) 
Candidiasis  1  0/325 (0.00%)  1/325 (0.31%) 
Catheter site infection  1  2/325 (0.62%)  0/325 (0.00%) 
Cellulitis  1  1/325 (0.31%)  1/325 (0.31%) 
Clostridial infection  1  1/325 (0.31%)  1/325 (0.31%) 
Clostridium difficile colitis  1  2/325 (0.62%)  0/325 (0.00%) 
Device related infection  1  2/325 (0.62%)  1/325 (0.31%) 
Erysipelas  1  1/325 (0.31%)  0/325 (0.00%) 
Escherichia infection  1  1/325 (0.31%)  0/325 (0.00%) 
Gastroenteritis  1  1/325 (0.31%)  0/325 (0.00%) 
H1N1 influenza  1  1/325 (0.31%)  0/325 (0.00%) 
Herpes zoster  1  0/325 (0.00%)  1/325 (0.31%) 
Herpes zoster ophthalmic  1  0/325 (0.00%)  1/325 (0.31%) 
Infection  1  3/325 (0.92%)  2/325 (0.62%) 
Influenza  1  1/325 (0.31%)  0/325 (0.00%) 
Laryngotracheitis obstructive  1  1/325 (0.31%)  0/325 (0.00%) 
Lobar pneumonia  1  0/325 (0.00%)  2/325 (0.62%) 
Localised infection  1  1/325 (0.31%)  0/325 (0.00%) 
Lower respiratory tract infection  1  2/325 (0.62%)  0/325 (0.00%) 
Lung abscess  1  1/325 (0.31%)  0/325 (0.00%) 
Lung infection  1  0/325 (0.00%)  1/325 (0.31%) 
Lung infection pseudomonal  1  1/325 (0.31%)  0/325 (0.00%) 
Lymphangitis  1  1/325 (0.31%)  0/325 (0.00%) 
Myiasis  1  0/325 (0.00%)  1/325 (0.31%) 
Neutropenic sepsis  1  2/325 (0.62%)  0/325 (0.00%) 
Oral candidiasis  1  1/325 (0.31%)  0/325 (0.00%) 
Parotitis  1  1/325 (0.31%)  0/325 (0.00%) 
Pleural infection bacterial  1  0/325 (0.00%)  1/325 (0.31%) 
Pneumonia  1  10/325 (3.08%)  13/325 (4.00%) 
Pulmonary sepsis  1  1/325 (0.31%)  0/325 (0.00%) 
Respiratory moniliasis  1  1/325 (0.31%)  0/325 (0.00%) 
Respiratory tract infection  1  2/325 (0.62%)  2/325 (0.62%) 
Sepsis  1  7/325 (2.15%)  5/325 (1.54%) 
Septic shock  1  2/325 (0.62%)  2/325 (0.62%) 
Skin infection  1  1/325 (0.31%)  0/325 (0.00%) 
Soft tissue infection  1  0/325 (0.00%)  1/325 (0.31%) 
Staphylococcal infection  1  0/325 (0.00%)  1/325 (0.31%) 
Staphylococcal sepsis  1  0/325 (0.00%)  1/325 (0.31%) 
Urinary tract infection  1  0/325 (0.00%)  1/325 (0.31%) 
Viral infection  1  1/325 (0.31%)  0/325 (0.00%) 
Wound infection  1  0/325 (0.00%)  1/325 (0.31%) 
Injury, poisoning and procedural complications     
Contrast media reaction  1  1/325 (0.31%)  0/325 (0.00%) 
Gastrointestinal stoma complication  1  1/325 (0.31%)  0/325 (0.00%) 
Head injury  1  0/325 (0.00%)  1/325 (0.31%) 
Jaw fracture  1  1/325 (0.31%)  0/325 (0.00%) 
Overdose  1  0/325 (0.00%)  1/325 (0.31%) 
Rib fracture  1  0/325 (0.00%)  1/325 (0.31%) 
Skin laceration  1  1/325 (0.31%)  0/325 (0.00%) 
Spinal cord injury  1  1/325 (0.31%)  0/325 (0.00%) 
Spinal shock  1  1/325 (0.31%)  0/325 (0.00%) 
Therapeutic agent toxicity  1  1/325 (0.31%)  0/325 (0.00%) 
Tibia fracture  1  0/325 (0.00%)  1/325 (0.31%) 
Wound dehiscence  1  0/325 (0.00%)  1/325 (0.31%) 
Investigations     
Blood creatinine increased  1  0/325 (0.00%)  1/325 (0.31%) 
C-reactive protein increased  1  0/325 (0.00%)  1/325 (0.31%) 
Neutrophil count decreased  1  0/325 (0.00%)  1/325 (0.31%) 
Urine output decreased  1  0/325 (0.00%)  1/325 (0.31%) 
Weight decreased  1  4/325 (1.23%)  1/325 (0.31%) 
White blood cell count decreased  1  0/325 (0.00%)  1/325 (0.31%) 
Metabolism and nutrition disorders     
Cachexia  1  2/325 (0.62%)  0/325 (0.00%) 
Decreased appetite  1  4/325 (1.23%)  9/325 (2.77%) 
Dehydration  1  16/325 (4.92%)  8/325 (2.46%) 
Electrolyte imbalance  1  0/325 (0.00%)  1/325 (0.31%) 
Feeding disorder  1  1/325 (0.31%)  0/325 (0.00%) 
Hyperglycaemia  1  0/325 (0.00%)  2/325 (0.62%) 
Hyperkalaemia  1  0/325 (0.00%)  1/325 (0.31%) 
Hypoalbuminaemia  1  0/325 (0.00%)  1/325 (0.31%) 
Hypocalcaemia  1  2/325 (0.62%)  2/325 (0.62%) 
Hypoglycaemia  1  1/325 (0.31%)  0/325 (0.00%) 
Hypokalaemia  1  11/325 (3.38%)  2/325 (0.62%) 
Hypomagnesaemia  1  5/325 (1.54%)  2/325 (0.62%) 
Hyponatraemia  1  2/325 (0.62%)  2/325 (0.62%) 
Hypophagia  1  0/325 (0.00%)  1/325 (0.31%) 
Hypophosphataemia  1  0/325 (0.00%)  1/325 (0.31%) 
Malnutrition  1  2/325 (0.62%)  0/325 (0.00%) 
Metabolic acidosis  1  1/325 (0.31%)  0/325 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/325 (0.62%)  0/325 (0.00%) 
Fistula  1  0/325 (0.00%)  1/325 (0.31%) 
Hypercreatinaemia  1  1/325 (0.31%)  0/325 (0.00%) 
Myalgia  1  0/325 (0.00%)  1/325 (0.31%) 
Neck pain  1  0/325 (0.00%)  1/325 (0.31%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/325 (0.31%)  1/325 (0.31%) 
Head and neck cancer  1  1/325 (0.31%)  1/325 (0.31%) 
Hypopharyngeal cancer  1  1/325 (0.31%)  0/325 (0.00%) 
Infected neoplasm  1  1/325 (0.31%)  0/325 (0.00%) 
Laryngeal cancer  1  0/325 (0.00%)  1/325 (0.31%) 
Lip and/or oral cavity cancer  1  0/325 (0.00%)  2/325 (0.62%) 
Metastases to central nervous system  1  1/325 (0.31%)  0/325 (0.00%) 
Metastases to liver  1  0/325 (0.00%)  1/325 (0.31%) 
Metastatic neoplasm  1  0/325 (0.00%)  1/325 (0.31%) 
Neoplasm progression  1  1/325 (0.31%)  0/325 (0.00%) 
Oropharyngeal neoplasm  1  0/325 (0.00%)  1/325 (0.31%) 
Pharyngeal cancer stage unspecified  1  0/325 (0.00%)  1/325 (0.31%) 
Squamous cell carcinoma  1  1/325 (0.31%)  0/325 (0.00%) 
Tongue neoplasm malignant stage unspecified  1  0/325 (0.00%)  2/325 (0.62%) 
Tumour associated fever  1  0/325 (0.00%)  1/325 (0.31%) 
Tumour haemorrhage  1  1/325 (0.31%)  6/325 (1.85%) 
Tumour pain  1  0/325 (0.00%)  1/325 (0.31%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/325 (0.31%)  1/325 (0.31%) 
Cerebral ischaemia  1  2/325 (0.62%)  0/325 (0.00%) 
Cerebrovascular accident  1  3/325 (0.92%)  0/325 (0.00%) 
Coma  1  0/325 (0.00%)  1/325 (0.31%) 
Convulsion  1  2/325 (0.62%)  1/325 (0.31%) 
Depressed level of consciousness  1  0/325 (0.00%)  1/325 (0.31%) 
Dizziness  1  1/325 (0.31%)  3/325 (0.92%) 
Encephalopathy  1  0/325 (0.00%)  2/325 (0.62%) 
Epilepsy  1  1/325 (0.31%)  0/325 (0.00%) 
Extrapyramidal disorder  1  0/325 (0.00%)  1/325 (0.31%) 
Grand mal convulsion  1  1/325 (0.31%)  0/325 (0.00%) 
Headache  1  1/325 (0.31%)  0/325 (0.00%) 
Hemiparesis  1  1/325 (0.31%)  1/325 (0.31%) 
Ischaemic stroke  1  3/325 (0.92%)  2/325 (0.62%) 
Lethargy  1  1/325 (0.31%)  0/325 (0.00%) 
Loss of consciousness  1  0/325 (0.00%)  1/325 (0.31%) 
Motor dysfunction  1  1/325 (0.31%)  0/325 (0.00%) 
Neuropathy peripheral  1  0/325 (0.00%)  2/325 (0.62%) 
Peripheral motor neuropathy  1  1/325 (0.31%)  0/325 (0.00%) 
Presyncope  1  0/325 (0.00%)  1/325 (0.31%) 
Radiculitis lumbosacral  1  0/325 (0.00%)  1/325 (0.31%) 
Syncope  1  3/325 (0.92%)  1/325 (0.31%) 
Transient ischaemic attack  1  1/325 (0.31%)  0/325 (0.00%) 
Psychiatric disorders     
Agitation  1  1/325 (0.31%)  0/325 (0.00%) 
Completed suicide  1  0/325 (0.00%)  1/325 (0.31%) 
Confusional state  1  3/325 (0.92%)  1/325 (0.31%) 
Depression  1  0/325 (0.00%)  1/325 (0.31%) 
Mental status changes  1  1/325 (0.31%)  0/325 (0.00%) 
Renal and urinary disorders     
Anuria  1  0/325 (0.00%)  1/325 (0.31%) 
Nephropathy toxic  1  1/325 (0.31%)  1/325 (0.31%) 
Renal failure  1  5/325 (1.54%)  5/325 (1.54%) 
Renal failure acute  1  3/325 (0.92%)  3/325 (0.92%) 
Renal impairment  1  1/325 (0.31%)  1/325 (0.31%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/325 (0.31%)  0/325 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Anoxia  1  1/325 (0.31%)  0/325 (0.00%) 
Apnoea  1  0/325 (0.00%)  1/325 (0.31%) 
Asphyxia  1  2/325 (0.62%)  1/325 (0.31%) 
Aspiration  1  1/325 (0.31%)  0/325 (0.00%) 
Bronchopneumopathy  1  1/325 (0.31%)  0/325 (0.00%) 
Chronic obstructive pulmonary disease  1  1/325 (0.31%)  1/325 (0.31%) 
Dyspnoea  1  1/325 (0.31%)  3/325 (0.92%) 
Epistaxis  1  0/325 (0.00%)  1/325 (0.31%) 
Haemoptysis  1  0/325 (0.00%)  1/325 (0.31%) 
Hypoxia  1  1/325 (0.31%)  1/325 (0.31%) 
Increased viscosity of bronchial secretion  1  0/325 (0.00%)  1/325 (0.31%) 
Laryngeal dyspnoea  1  0/325 (0.00%)  1/325 (0.31%) 
Lung disorder  1  1/325 (0.31%)  0/325 (0.00%) 
Obstructive airways disorder  1  1/325 (0.31%)  0/325 (0.00%) 
Pneumonia aspiration  1  5/325 (1.54%)  4/325 (1.23%) 
Pneumonitis  1  1/325 (0.31%)  2/325 (0.62%) 
Pneumothorax  1  3/325 (0.92%)  0/325 (0.00%) 
Productive cough  1  1/325 (0.31%)  0/325 (0.00%) 
Pulmonary embolism  1  3/325 (0.92%)  3/325 (0.92%) 
Pulmonary haemorrhage  1  0/325 (0.00%)  1/325 (0.31%) 
Pulmonary oedema  1  1/325 (0.31%)  0/325 (0.00%) 
Respiratory disorder  1  0/325 (0.00%)  1/325 (0.31%) 
Respiratory distress  1  2/325 (0.62%)  0/325 (0.00%) 
Respiratory failure  1  1/325 (0.31%)  3/325 (0.92%) 
Respiratory tract haemorrhage  1  0/325 (0.00%)  1/325 (0.31%) 
Tracheal stenosis  1  1/325 (0.31%)  0/325 (0.00%) 
Upper airway obstruction  1  1/325 (0.31%)  0/325 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform  1  1/325 (0.31%)  0/325 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/325 (0.00%)  1/325 (0.31%) 
Psoriasis  1  1/325 (0.31%)  0/325 (0.00%) 
Rash  1  3/325 (0.92%)  0/325 (0.00%) 
Skin disorder  1  1/325 (0.31%)  1/325 (0.31%) 
Skin ulcer  1  1/325 (0.31%)  0/325 (0.00%) 
Vascular disorders     
Circulatory collapse  1  1/325 (0.31%)  0/325 (0.00%) 
Deep vein thrombosis  1  4/325 (1.23%)  0/325 (0.00%) 
Haemorrhage  1  2/325 (0.62%)  0/325 (0.00%) 
Hypertension  1  1/325 (0.31%)  0/325 (0.00%) 
Hypertensive crisis  1  1/325 (0.31%)  0/325 (0.00%) 
Hypotension  1  7/325 (2.15%)  2/325 (0.62%) 
Hypovolaemic shock  1  1/325 (0.31%)  0/325 (0.00%) 
Iliac artery embolism  1  1/325 (0.31%)  0/325 (0.00%) 
Infarction  1  1/325 (0.31%)  0/325 (0.00%) 
Jugular vein thrombosis  1  1/325 (0.31%)  0/325 (0.00%) 
Orthostatic hypotension  1  0/325 (0.00%)  2/325 (0.62%) 
Peripheral arterial occlusive disease  1  1/325 (0.31%)  0/325 (0.00%) 
Phlebitis  1  1/325 (0.31%)  0/325 (0.00%) 
Thrombosis  1  3/325 (0.92%)  1/325 (0.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab Plus Chemotherapy Chemotherapy Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   311/325 (95.69%)   301/325 (92.62%) 
Blood and lymphatic system disorders     
Anaemia  1  132/325 (40.62%)  126/325 (38.77%) 
Leukopenia  1  51/325 (15.69%)  49/325 (15.08%) 
Neutropenia  1  157/325 (48.31%)  140/325 (43.08%) 
Thrombocytopenia  1  74/325 (22.77%)  74/325 (22.77%) 
Ear and labyrinth disorders     
Tinnitus  1  21/325 (6.46%)  28/325 (8.62%) 
Eye disorders     
Conjunctivitis  1  23/325 (7.08%)  4/325 (1.23%) 
Gastrointestinal disorders     
Abdominal pain  1  20/325 (6.15%)  10/325 (3.08%) 
Abdominal pain upper  1  22/325 (6.77%)  18/325 (5.54%) 
Constipation  1  83/325 (25.54%)  74/325 (22.77%) 
Diarrhoea  1  123/325 (37.85%)  76/325 (23.38%) 
Dyspepsia  1  25/325 (7.69%)  20/325 (6.15%) 
Dysphagia  1  23/325 (7.08%)  24/325 (7.38%) 
Nausea  1  178/325 (54.77%)  180/325 (55.38%) 
Stomatitis  1  67/325 (20.62%)  62/325 (19.08%) 
Vomiting  1  140/325 (43.08%)  126/325 (38.77%) 
General disorders     
Asthenia  1  65/325 (20.00%)  54/325 (16.62%) 
Fatigue  1  90/325 (27.69%)  81/325 (24.92%) 
Mucosal inflammation  1  71/325 (21.85%)  62/325 (19.08%) 
Oedema peripheral  1  21/325 (6.46%)  22/325 (6.77%) 
Pyrexia  1  50/325 (15.38%)  45/325 (13.85%) 
Infections and infestations     
Paronychia  1  36/325 (11.08%)  1/325 (0.31%) 
Investigations     
Blood creatinine increased  1  23/325 (7.08%)  33/325 (10.15%) 
Weight decreased  1  81/325 (24.92%)  54/325 (16.62%) 
Metabolism and nutrition disorders     
Decreased appetite  1  94/325 (28.92%)  90/325 (27.69%) 
Hypocalcaemia  1  42/325 (12.92%)  20/325 (6.15%) 
Hypokalaemia  1  47/325 (14.46%)  43/325 (13.23%) 
Hypomagnesaemia  1  132/325 (40.62%)  66/325 (20.31%) 
Hyponatraemia  1  26/325 (8.00%)  16/325 (4.92%) 
Musculoskeletal and connective tissue disorders     
Neck pain  1  15/325 (4.62%)  20/325 (6.15%) 
Nervous system disorders     
Dizziness  1  28/325 (8.62%)  21/325 (6.46%) 
Headache  1  29/325 (8.92%)  35/325 (10.77%) 
Neuropathy peripheral  1  27/325 (8.31%)  20/325 (6.15%) 
Psychiatric disorders     
Insomnia  1  27/325 (8.31%)  21/325 (6.46%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  41/325 (12.62%)  30/325 (9.23%) 
Dyspnoea  1  31/325 (9.54%)  19/325 (5.85%) 
Oropharyngeal pain  1  11/325 (3.38%)  19/325 (5.85%) 
Skin and subcutaneous tissue disorders     
Acne  1  27/325 (8.31%)  3/325 (0.92%) 
Alopecia  1  49/325 (15.08%)  36/325 (11.08%) 
Dermatitis acneiform  1  48/325 (14.77%)  0/325 (0.00%) 
Dry skin  1  45/325 (13.85%)  4/325 (1.23%) 
Erythema  1  26/325 (8.00%)  3/325 (0.92%) 
Pruritus  1  47/325 (14.46%)  5/325 (1.54%) 
Rash  1  165/325 (50.77%)  9/325 (2.77%) 
Skin fissures  1  24/325 (7.38%)  0/325 (0.00%) 
Vascular disorders     
Hypertension  1  16/325 (4.92%)  19/325 (5.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. 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 multi-center 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
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00460265     History of Changes
Other Study ID Numbers: 20050251
First Submitted: April 12, 2007
First Posted: April 13, 2007
Results First Submitted: May 13, 2011
Results First Posted: June 14, 2011
Last Update Posted: March 7, 2014