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Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00111761
Recruitment Status : Completed
First Posted : May 26, 2005
Results First Posted : June 3, 2011
Last Update Posted : December 12, 2013
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 Colorectal Cancer
Interventions Drug: Irinotecan
Biological: Panitumumab
Drug: 5-Fluorouracil
Drug: Leucovorin
Enrollment 43
Recruitment Details Participants were enrolled from 19 Jul 2002 through 20 April 2004
Pre-assignment Details  
Arm/Group Title Panitumumab With FOLFIRI Panitumumab With IFL
Hide Arm/Group Description Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen) Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Period Title: Part 1
Started 0 [1] 19
Completed 0 14 [2]
Not Completed 0 5
Reason Not Completed
Physician Decision             0             1
Death             0             2
Other             0             1
Withdrawal by Subject             0             1
[1]
This treatment group was not initiated until Part 2
[2]
Completed through safety followup
Period Title: Part 2
Started 24 0 [1]
Completed 16 0
Not Completed 8 0
Reason Not Completed
Adverse Event             1             0
Physician Decision             1             0
Death             1             0
Disease progression             3             0
Protocol-specified criteria             1             0
Other             1             0
[1]
This treatment group was used in Part 1 only
Arm/Group Title Panitumumab With IFL Panitumumab With FOLFIRI Total
Hide Arm/Group Description Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen) Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen) Total of all reporting groups
Overall Number of Baseline Participants 19 24 43
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 24 participants 43 participants
56.6  (12.1) 60.7  (15.0) 58.9  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 24 participants 43 participants
Female
3
  15.8%
10
  41.7%
13
  30.2%
Male
16
  84.2%
14
  58.3%
30
  69.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 24 participants 43 participants
Asian 1 1 2
Black or African American 4 3 7
Hispanic or Latino 1 2 3
White or Caucasian 13 18 31
Other 0 0 0
1.Primary Outcome
Title Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 2)
Hide Description The number of participants with grade 3 or grade 4 diarrhea in Part 2 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).
Time Frame Until disease progression (median 47 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy.
Arm/Group Title Panitumumab With FOLFIRI
Hide Arm/Group Description:
Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Participants
6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab With FOLFIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 25.0
Confidence Interval 95%
9.8 to 46.7
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Grade 3 or Grade 4 Diarrhea (Part 1)
Hide Description The number of participants with grade 3 or grade 4 diarrhea in Part 1 of the study. Grading of diarrhea followed the grading scale in Version 2.0 of the National Cancer Institute Common Toxicity Criteria (NCI CTC).
Time Frame Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab With IFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 58
Confidence Interval 95%
34 to 80
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With an Objective Tumor Response (Part 2)
Hide Description Objective tumor response (complete or partial) in Part 2 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.
Time Frame Until disease progression (median 47 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy
Arm/Group Title Panitumumab With FOLFIRI
Hide Arm/Group Description:
Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Participants
8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab With FOLFIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 33.3
Confidence Interval 95%
15.6 to 55.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Disease Progression (Part 2)
Hide Description Kaplan-Meier estimate of median time from the first dose of study drug to first observed disease progression or death if the death was due to disease progression (whichever comes first) in Part 2 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.
Time Frame From enrollment until death or diease progression. Maximum follow-up time was 16 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy
Arm/Group Title Panitumumab With FOLFIRI
Hide Arm/Group Description:
Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: weeks
47.3 [1] 
(26.0 to NA)
[1]
Could not be estimated due to the low number of events.
5.Secondary Outcome
Title Progression-free Survival Time (Part 2)
Hide Description Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 2 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.
Time Frame From enrollment until disease progression or death. Maximum follow-up time was 16 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy
Arm/Group Title Panitumumab With FOLFIRI
Hide Arm/Group Description:
Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: weeks
41.1 [1] 
(26.0 to NA)
[1]
Could not be estimated due to the low number of events.
6.Secondary Outcome
Title Survival Time (Part 2)
Hide Description Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.
Time Frame From enrollment until death. Maximum follow-up time was 16 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: weeks
73.1 [1] 
(59.4 to NA)
[1]
Could not be estimated due to the low number of events.
7.Secondary Outcome
Title Number of Participants Who Died (Part 2)
Hide Description The number of participants in Part 2 who died during the study.
Time Frame From enrollment until last contact. Maximum follow-up was 16 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of participants who received at least one dose of panitumumab or one dose of chemotherapy
Arm/Group Title Panitumumab With FOLFIRI
Hide Arm/Group Description:
Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
6
8.Secondary Outcome
Title Number of Participants With Objective Tumor Response (Part 1)
Hide Description Objective tumor response (complete or partial) in Part 1 of the study, based on Response Evaluation Criteria in Solid Tumors (RECIST), where complete response = disappearance of all target lesions, partial response = ≥30% reduction in lesion size, progressive disease = ≥20% increase in tumor size; otherwise stable disease.
Time Frame Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panitumumab With IFL
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 47.4
Confidence Interval 95%
24.4 to 71.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Progression-free Survival Time (Part 1)
Hide Description Kaplan-Meier estimate of median time from enrollment to death or disease progression in Part 1 of the study. Participants who had not progressed and had not died were censored at their last disease assessment date.
Time Frame From enrollment until disease progression or death. Maximum follow-up time was 25 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: weeks
24.3
(19.0 to 36.0)
10.Secondary Outcome
Title Time to Disease Progression (Part 1)
Hide Description Kaplan-Meier estimate of the median time from the first dose of study drug to disease progression or death if due to disease progression (whichever comes first) in Part 1 of the study. Participants who had not progressed or died for reasons other than disease progression were censored at their last disease assessment date.
Time Frame From enrollment until disease progression or death. Maximum follow-up time was 25 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: weeks
35.0
(21.7 to 72.0)
11.Secondary Outcome
Title Survival Time (Part 1)
Hide Description Kaplan-Meier estimate of the median time from enrollment to death from any cause. Participants who did not die on study were censored at their last contact date.
Time Frame From enrollment until death. Maximum follow-up time was 25 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: weeks
73.1 [1] 
(59.4 to NA)
[1]
Could not be estimated due to the low number of events.
12.Secondary Outcome
Title Time to Treatment Failure (Part 1)
Hide Description Kaplan-Meier estimate of the median time from the date of first dose of panitumumab or chemotherapy to the date the decision was made to end treatment for any reason in Part 1 of the study.
Time Frame Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: Weeks
24.3
(7.9 to 36.0)
13.Secondary Outcome
Title Time to Initial Objective Tumor Response (Part 1)
Hide Description Median time to first observed objective tumor response (complete or partial) among responders in Part 1 of the study.
Time Frame Until disease progression (median 35 weeks) or 48 weeks, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Subjects Treated Analysis Set, composed of all consented participants who received at least 1 dose of panitumumab and at least 1 dose of chemotherapy, who had an objective tumor response.
Arm/Group Title Panitumumab With IFL
Hide Arm/Group Description:
Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
Overall Number of Participants Analyzed 9
Median (Inter-Quartile Range)
Unit of Measure: weeks
5.9
(5.4 to 11.3)
Time Frame First dose through maximum of safety FU or 30 days after last dose (median 47 weeks follow-up)
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 IFL Panitumumab Plus FOLFIRI
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Panitumumab Plus IFL Panitumumab Plus FOLFIRI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panitumumab Plus IFL Panitumumab Plus FOLFIRI
Affected / at Risk (%) Affected / at Risk (%)
Total   12/19 (63.16%)   11/24 (45.83%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  2/19 (10.53%)  0/24 (0.00%) 
Cardiac disorders     
Cardiac failure congestive  1  0/19 (0.00%)  1/24 (4.17%) 
Gastrointestinal disorders     
Abdominal pain  1  2/19 (10.53%)  0/24 (0.00%) 
Diarrhoea  1  8/19 (42.11%)  1/24 (4.17%) 
Gastrointestinal haemorrhage  1  0/19 (0.00%)  1/24 (4.17%) 
Ileus paralytic  1  1/19 (5.26%)  0/24 (0.00%) 
Intestinal fistula  1  0/19 (0.00%)  1/24 (4.17%) 
Rectal haemorrhage  1  1/19 (5.26%)  0/24 (0.00%) 
Small intestinal obstruction  1  1/19 (5.26%)  0/24 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/19 (5.26%)  0/24 (0.00%) 
General disorders     
Chest pain  1  0/19 (0.00%)  2/24 (8.33%) 
Chills  1  0/19 (0.00%)  1/24 (4.17%) 
Mucosal inflammation  1  0/19 (0.00%)  1/24 (4.17%) 
Pyrexia  1  1/19 (5.26%)  1/24 (4.17%) 
Infections and infestations     
Abdominal abscess  1  0/19 (0.00%)  1/24 (4.17%) 
Bacteraemia  1  0/19 (0.00%)  1/24 (4.17%) 
Catheter related infection  1  0/19 (0.00%)  1/24 (4.17%) 
Cellulitis  1  0/19 (0.00%)  2/24 (8.33%) 
Sepsis  1  0/19 (0.00%)  2/24 (8.33%) 
Staphylococcal sepsis  1  0/19 (0.00%)  1/24 (4.17%) 
Urinary tract infection  1  0/19 (0.00%)  1/24 (4.17%) 
Investigations     
Coagulation time prolonged  1  0/19 (0.00%)  1/24 (4.17%) 
Metabolism and nutrition disorders     
Dehydration  1  2/19 (10.53%)  0/24 (0.00%) 
Hypomagnesaemia  1  1/19 (5.26%)  0/24 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer metastatic  1  1/19 (5.26%)  0/24 (0.00%) 
Colon neoplasm  1  1/19 (5.26%)  0/24 (0.00%) 
Colorectal cancer metastatic  1  1/19 (5.26%)  0/24 (0.00%) 
Renal and urinary disorders     
Haematuria  1  0/19 (0.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  1/19 (5.26%)  0/24 (0.00%) 
Dyspnoea  1  0/19 (0.00%)  1/24 (4.17%) 
Pulmonary embolism  1  1/19 (5.26%)  2/24 (8.33%) 
Vascular disorders     
Deep vein thrombosis  1  0/19 (0.00%)  1/24 (4.17%) 
Haemorrhage  1  0/19 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panitumumab Plus IFL Panitumumab Plus FOLFIRI
Affected / at Risk (%) Affected / at Risk (%)
Total   19/19 (100.00%)   24/24 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  6/19 (31.58%)  3/24 (12.50%) 
Leukopenia  1  2/19 (10.53%)  1/24 (4.17%) 
Neutropenia  1  6/19 (31.58%)  3/24 (12.50%) 
Cardiac disorders     
Angina pectoris  1  1/19 (5.26%)  0/24 (0.00%) 
Atrial fibrillation  1  2/19 (10.53%)  1/24 (4.17%) 
Palpitations  1  1/19 (5.26%)  1/24 (4.17%) 
Eye disorders     
Blepharitis  1  1/19 (5.26%)  0/24 (0.00%) 
Conjunctivitis  1  2/19 (10.53%)  4/24 (16.67%) 
Diplopia  1  1/19 (5.26%)  0/24 (0.00%) 
Eye haemorrhage  1  1/19 (5.26%)  0/24 (0.00%) 
Eye irritation  1  2/19 (10.53%)  0/24 (0.00%) 
Eye pruritus  1  0/19 (0.00%)  3/24 (12.50%) 
Eyelid oedema  1  0/19 (0.00%)  2/24 (8.33%) 
Growth of eyelashes  1  1/19 (5.26%)  0/24 (0.00%) 
Keratoconjunctivitis sicca  1  1/19 (5.26%)  0/24 (0.00%) 
Lacrimation increased  1  1/19 (5.26%)  2/24 (8.33%) 
Vision blurred  1  2/19 (10.53%)  4/24 (16.67%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/19 (5.26%)  1/24 (4.17%) 
Abdominal distension  1  1/19 (5.26%)  1/24 (4.17%) 
Abdominal pain  1  8/19 (42.11%)  8/24 (33.33%) 
Abdominal pain upper  1  1/19 (5.26%)  3/24 (12.50%) 
Abdominal tenderness  1  1/19 (5.26%)  0/24 (0.00%) 
Anal discomfort  1  1/19 (5.26%)  0/24 (0.00%) 
Colitis  1  1/19 (5.26%)  0/24 (0.00%) 
Constipation  1  7/19 (36.84%)  10/24 (41.67%) 
Defaecation urgency  1  1/19 (5.26%)  0/24 (0.00%) 
Diarrhoea  1  16/19 (84.21%)  19/24 (79.17%) 
Dry mouth  1  1/19 (5.26%)  6/24 (25.00%) 
Dyspepsia  1  3/19 (15.79%)  4/24 (16.67%) 
Dysphagia  1  2/19 (10.53%)  1/24 (4.17%) 
Epigastric discomfort  1  1/19 (5.26%)  0/24 (0.00%) 
Flatulence  1  4/19 (21.05%)  4/24 (16.67%) 
Frequent bowel movements  1  1/19 (5.26%)  1/24 (4.17%) 
Gastrooesophageal reflux disease  1  1/19 (5.26%)  2/24 (8.33%) 
Glossodynia  1  2/19 (10.53%)  0/24 (0.00%) 
Haematochezia  1  3/19 (15.79%)  2/24 (8.33%) 
Haemorrhoids  1  1/19 (5.26%)  2/24 (8.33%) 
Hypertrophy of tongue papillae  1  1/19 (5.26%)  0/24 (0.00%) 
Intestinal stenosis  1  1/19 (5.26%)  0/24 (0.00%) 
Loose stools  1  3/19 (15.79%)  0/24 (0.00%) 
Mouth ulceration  1  1/19 (5.26%)  0/24 (0.00%) 
Nausea  1  13/19 (68.42%)  15/24 (62.50%) 
Oral pain  1  2/19 (10.53%)  4/24 (16.67%) 
Proctalgia  1  1/19 (5.26%)  1/24 (4.17%) 
Rectal discharge  1  1/19 (5.26%)  0/24 (0.00%) 
Rectal haemorrhage  1  5/19 (26.32%)  1/24 (4.17%) 
Retching  1  0/19 (0.00%)  2/24 (8.33%) 
Sensitivity of teeth  1  1/19 (5.26%)  0/24 (0.00%) 
Small intestinal obstruction  1  1/19 (5.26%)  0/24 (0.00%) 
Stomatitis  1  8/19 (42.11%)  6/24 (25.00%) 
Vomiting  1  5/19 (26.32%)  11/24 (45.83%) 
General disorders     
Asthenia  1  2/19 (10.53%)  6/24 (25.00%) 
Catheter site pain  1  0/19 (0.00%)  2/24 (8.33%) 
Chest discomfort  1  2/19 (10.53%)  0/24 (0.00%) 
Chest pain  1  1/19 (5.26%)  2/24 (8.33%) 
Fatigue  1  16/19 (84.21%)  19/24 (79.17%) 
Influenza like illness  1  1/19 (5.26%)  0/24 (0.00%) 
Infusion site pain  1  1/19 (5.26%)  0/24 (0.00%) 
Infusion site reaction  1  1/19 (5.26%)  0/24 (0.00%) 
Injection site reaction  1  1/19 (5.26%)  0/24 (0.00%) 
Malaise  1  1/19 (5.26%)  0/24 (0.00%) 
Mucosal inflammation  1  0/19 (0.00%)  9/24 (37.50%) 
Oedema  1  0/19 (0.00%)  3/24 (12.50%) 
Oedema peripheral  1  7/19 (36.84%)  4/24 (16.67%) 
Pain  1  3/19 (15.79%)  3/24 (12.50%) 
Pyrexia  1  5/19 (26.32%)  5/24 (20.83%) 
Rigors  1  1/19 (5.26%)  0/24 (0.00%) 
Hepatobiliary disorders     
Portal vein thrombosis  1  1/19 (5.26%)  0/24 (0.00%) 
Infections and infestations     
Abscess limb  1  1/19 (5.26%)  0/24 (0.00%) 
Biliary tract infection  1  1/19 (5.26%)  0/24 (0.00%) 
Catheter related infection  1  0/19 (0.00%)  2/24 (8.33%) 
Cellulitis orbital  1  1/19 (5.26%)  0/24 (0.00%) 
Ear infection  1  1/19 (5.26%)  0/24 (0.00%) 
Eye infection  1  1/19 (5.26%)  1/24 (4.17%) 
Fungal infection  1  1/19 (5.26%)  1/24 (4.17%) 
Fungal skin infection  1  0/19 (0.00%)  2/24 (8.33%) 
Furuncle  1  1/19 (5.26%)  1/24 (4.17%) 
Gastroenteritis viral  1  1/19 (5.26%)  0/24 (0.00%) 
Genital candidiasis  1  1/19 (5.26%)  0/24 (0.00%) 
Infection  1  1/19 (5.26%)  0/24 (0.00%) 
Localised infection  1  2/19 (10.53%)  2/24 (8.33%) 
Nail infection  1  1/19 (5.26%)  0/24 (0.00%) 
Nasopharyngitis  1  3/19 (15.79%)  1/24 (4.17%) 
Paronychia  1  4/19 (21.05%)  1/24 (4.17%) 
Pharyngitis  1  2/19 (10.53%)  0/24 (0.00%) 
Rash pustular  1  0/19 (0.00%)  4/24 (16.67%) 
Skin infection  1  1/19 (5.26%)  0/24 (0.00%) 
Staphylococcal infection  1  2/19 (10.53%)  0/24 (0.00%) 
Upper respiratory tract infection  1  1/19 (5.26%)  4/24 (16.67%) 
Urinary tract infection  1  0/19 (0.00%)  5/24 (20.83%) 
Injury, poisoning and procedural complications     
Skin laceration  1  0/19 (0.00%)  3/24 (12.50%) 
Investigations     
Alanine aminotransferase increased  1  1/19 (5.26%)  1/24 (4.17%) 
Blood bilirubin increased  1  1/19 (5.26%)  0/24 (0.00%) 
Ejection fraction abnormal  1  1/19 (5.26%)  0/24 (0.00%) 
Ejection fraction decreased  1  2/19 (10.53%)  0/24 (0.00%) 
Neutrophil count decreased  1  1/19 (5.26%)  0/24 (0.00%) 
Weight decreased  1  3/19 (15.79%)  4/24 (16.67%) 
Metabolism and nutrition disorders     
Anorexia  1  7/19 (36.84%)  13/24 (54.17%) 
Decreased appetite  1  2/19 (10.53%)  3/24 (12.50%) 
Dehydration  1  4/19 (21.05%)  5/24 (20.83%) 
Electrolyte imbalance  1  1/19 (5.26%)  0/24 (0.00%) 
Gout  1  2/19 (10.53%)  0/24 (0.00%) 
Hyperglycaemia  1  1/19 (5.26%)  0/24 (0.00%) 
Hypoalbuminaemia  1  3/19 (15.79%)  1/24 (4.17%) 
Hypocalcaemia  1  2/19 (10.53%)  0/24 (0.00%) 
Hypokalaemia  1  7/19 (36.84%)  6/24 (25.00%) 
Hypomagnesaemia  1  2/19 (10.53%)  6/24 (25.00%) 
Hyponatraemia  1  1/19 (5.26%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/19 (0.00%)  2/24 (8.33%) 
Back pain  1  2/19 (10.53%)  3/24 (12.50%) 
Facial pain  1  1/19 (5.26%)  0/24 (0.00%) 
Flank pain  1  0/19 (0.00%)  2/24 (8.33%) 
Local swelling  1  1/19 (5.26%)  0/24 (0.00%) 
Muscle spasms  1  0/19 (0.00%)  3/24 (12.50%) 
Musculoskeletal stiffness  1  1/19 (5.26%)  0/24 (0.00%) 
Myalgia  1  2/19 (10.53%)  3/24 (12.50%) 
Neck pain  1  1/19 (5.26%)  0/24 (0.00%) 
Pain in extremity  1  2/19 (10.53%)  4/24 (16.67%) 
Nervous system disorders     
Ageusia  1  1/19 (5.26%)  0/24 (0.00%) 
Cholinergic syndrome  1  0/19 (0.00%)  2/24 (8.33%) 
Dizziness  1  6/19 (31.58%)  8/24 (33.33%) 
Dysgeusia  1  2/19 (10.53%)  2/24 (8.33%) 
Headache  1  2/19 (10.53%)  5/24 (20.83%) 
Hypoaesthesia  1  1/19 (5.26%)  1/24 (4.17%) 
Memory impairment  1  2/19 (10.53%)  0/24 (0.00%) 
Paraesthesia  1  0/19 (0.00%)  3/24 (12.50%) 
Syncope  1  1/19 (5.26%)  1/24 (4.17%) 
Tremor  1  2/19 (10.53%)  0/24 (0.00%) 
Psychiatric disorders     
Anxiety  1  0/19 (0.00%)  3/24 (12.50%) 
Depression  1  4/19 (21.05%)  2/24 (8.33%) 
Insomnia  1  2/19 (10.53%)  7/24 (29.17%) 
Mood swings  1  1/19 (5.26%)  0/24 (0.00%) 
Nervousness  1  1/19 (5.26%)  0/24 (0.00%) 
Restlessness  1  1/19 (5.26%)  0/24 (0.00%) 
Renal and urinary disorders     
Dysuria  1  2/19 (10.53%)  3/24 (12.50%) 
Nephrolithiasis  1  1/19 (5.26%)  0/24 (0.00%) 
Nocturia  1  1/19 (5.26%)  1/24 (4.17%) 
Urinary retention  1  1/19 (5.26%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/19 (10.53%)  8/24 (33.33%) 
Dry throat  1  1/19 (5.26%)  0/24 (0.00%) 
Dysphonia  1  0/19 (0.00%)  3/24 (12.50%) 
Dyspnoea  1  1/19 (5.26%)  4/24 (16.67%) 
Dyspnoea exertional  1  1/19 (5.26%)  1/24 (4.17%) 
Epistaxis  1  3/19 (15.79%)  6/24 (25.00%) 
Hiccups  1  5/19 (26.32%)  0/24 (0.00%) 
Hoarseness  1  1/19 (5.26%)  0/24 (0.00%) 
Pharyngolaryngeal pain  1  0/19 (0.00%)  6/24 (25.00%) 
Pleural effusion  1  0/19 (0.00%)  2/24 (8.33%) 
Postnasal drip  1  1/19 (5.26%)  0/24 (0.00%) 
Productive cough  1  2/19 (10.53%)  0/24 (0.00%) 
Pulmonary embolism  1  1/19 (5.26%)  1/24 (4.17%) 
Rhinitis allergic  1  1/19 (5.26%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  6/19 (31.58%)  10/24 (41.67%) 
Cold sweat  1  1/19 (5.26%)  0/24 (0.00%) 
Dermatitis acneiform  1  4/19 (21.05%)  8/24 (33.33%) 
Dry skin  1  6/19 (31.58%)  10/24 (41.67%) 
Erythema  1  1/19 (5.26%)  6/24 (25.00%) 
Exfoliative rash  1  0/19 (0.00%)  2/24 (8.33%) 
Hair growth abnormal  1  1/19 (5.26%)  0/24 (0.00%) 
Hyperhidrosis  1  1/19 (5.26%)  2/24 (8.33%) 
Nail disorder  1  0/19 (0.00%)  3/24 (12.50%) 
Pain of skin  1  1/19 (5.26%)  1/24 (4.17%) 
Palmar erythema  1  1/19 (5.26%)  0/24 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  3/19 (15.79%)  2/24 (8.33%) 
Pruritus  1  5/19 (26.32%)  9/24 (37.50%) 
Rash  1  16/19 (84.21%)  19/24 (79.17%) 
Rash follicular  1  0/19 (0.00%)  2/24 (8.33%) 
Rash generalised  1  1/19 (5.26%)  0/24 (0.00%) 
Rash macular  1  0/19 (0.00%)  5/24 (20.83%) 
Rash maculo-papular  1  2/19 (10.53%)  3/24 (12.50%) 
Rash papular  1  2/19 (10.53%)  5/24 (20.83%) 
Rash pruritic  1  2/19 (10.53%)  1/24 (4.17%) 
Skin disorder  1  5/19 (26.32%)  1/24 (4.17%) 
Skin exfoliation  1  0/19 (0.00%)  4/24 (16.67%) 
Skin fissures  1  0/19 (0.00%)  6/24 (25.00%) 
Skin irritation  1  2/19 (10.53%)  0/24 (0.00%) 
Skin lesion  1  0/19 (0.00%)  2/24 (8.33%) 
Skin ulcer  1  2/19 (10.53%)  0/24 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/19 (5.26%)  2/24 (8.33%) 
Hot flush  1  0/19 (0.00%)  2/24 (8.33%) 
Hypertension  1  1/19 (5.26%)  1/24 (4.17%) 
Hypotension  1  3/19 (15.79%)  3/24 (12.50%) 
Phlebitis  1  1/19 (5.26%)  0/24 (0.00%) 
Thrombophlebitis superficial  1  1/19 (5.26%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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 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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Publications:
Berlin J, Malik I, Picus J, Glisson S, Kozloff M, Spitzer G, Wiens B, MacDonald M, Jerian S, Hecht JR.Panitumumab with Irinotecan, Leucovorin, and 5-Fluorouracil (IFL or FOLFIRI) for First-Line Treatment of Metastatic Colorectal Cancer.Journal-002322;2007;6(6):427-432
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00111761     History of Changes
Obsolete Identifiers: NCT00047151
Other Study ID Numbers: 20025409
First Submitted: May 25, 2005
First Posted: May 26, 2005
Results First Submitted: August 6, 2010
Results First Posted: June 3, 2011
Last Update Posted: December 12, 2013