SPECTRUM: Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00460265
Collaborator
(none)
658
2
60
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
658 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
May 1, 2010
Actual Study Completion Date
:
May 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ARM 2 Arm 2 consists of Cisplatin and 5-FU |
Drug: ARM 2
Subjects will receive Cisplatin plus 5FU
|
| Experimental: ARM 1 ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU |
Drug: ARM 1
Subjects will receive Panitumumab plus cisplatin and 5FU
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [Upto 56 months]
Time from randomization to death
Secondary Outcome Measures
- Overall Response Rate [Every 6 weeks until disease progression, up to 56 months]
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.
- Duration of Response [Every 6 weeks until disease progression, up to 56 months]
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 to Progression [Every 6 weeks until disease progression, up to 56 months]
Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)
- Time to Response [Every 6 weeks until disease progression, upto 56 months]
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.
- Progression Free Survival [Every 6 weeks until disease progression or deaths, upto 56 months]
Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Man or woman at least 18 years old.
-
Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
-
Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
-
Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
-
Measurable and non-measurable disease.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
-
History or known presence of Central Nervous System (CNS) metastases.
-
History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
-
Nasopharyngeal carcinoma.
-
Prior systemic treatment for metastatic and/or recurrent SCCHN
-
Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
-
Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
-
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
-
Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
-
Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521;
- Vermorken JB, Stöhlmacher-Williams J, Davidenko I, Licitra L, Winquist E, Villanueva C, Foa P, Rottey S, Skladowski K, Tahara M, Pai VR, Faivre S, Blajman CR, Forastiere AA, Stein BN, Oliner KS, Pan Z, Bach BA; SPECTRUM investigators. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697-710. doi: 10.1016/S1470-2045(13)70181-5. Epub 2013 Jun 6.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00460265
Other Study ID Numbers:
- 20050251
First Posted:
Apr 13, 2007
Last Update Posted:
Mar 7, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Amgen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled from 25 May 2007 to 10 March 2009. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Panitumumab Plus Chemotherapy | Chemotherapy Alone |
|---|---|---|
| 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 | 330 |
| Received Study Medication | 325 | 325 |
| COMPLETED | 243 | 241 |
| NOT COMPLETED | 85 | 89 |
Baseline Characteristics
| Arm/Group Title | Panitumumab Plus Chemotherapy | Chemotherapy Alone | Total |
|---|---|---|---|
| Arm/Group Description | Consists of Panitumumab plus Cisplatin and 5-FU | Consists of Cisplatin and 5-FU | Total of all reporting groups |
| Overall Participants | 327 | 330 | 657 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
57.6
(8.5)
|
58.6
(7.8)
|
58.1
(8.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
44
13.5%
|
43
13%
|
87
13.2%
|
| Male |
283
86.5%
|
287
87%
|
570
86.8%
|
| Race/Ethnicity, Customized (subjects) [Number] | |||
| 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 (subjects) [Number] | |||
| Yes |
267
|
263
|
530
|
| No |
60
|
67
|
127
|
| ECOG perfomance score, 0/1/2 (subjects) [Number] | |||
| 0 |
98
|
98
|
196
|
| 1 |
227
|
228
|
455
|
| 2 |
2
|
4
|
6
|
| Primary tumor site, oropharynx&larynx/oral cavity&hypopharynx (subjects) [Number] | |||
| Oropharynx and larynx |
186
|
191
|
377
|
| Oral cavity and hypopharynx |
141
|
139
|
280
|
Outcome Measures
| Title | Overall Survival |
|---|---|
| Description | Time from randomization to death |
| Time Frame | Upto 56 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention to treat (ITT) |
| Arm/Group Title | Panitumumab Plus Chemotherapy | Chemotherapy Alone |
|---|---|---|
| Arm/Group Description | Consists of Panitumumab plus Cisplatin and 5-FU | Consists of Cisplatin and 5-FU |
| Measure Participants | 327 | 330 |
| Median (95% Confidence Interval) [months] |
11.1
|
9.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Panitumumab Plus Chemotherapy, Chemotherapy Alone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1403 |
| Comments | ||
| 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 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone. | |
| Title | Overall Response Rate |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | Consists of Panitumumab plus Cisplatin and 5-FU | Consists of Cisplatin and 5-FU |
| Measure Participants | 278 | 288 |
| Number [subjects] |
101
|
73
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Panitumumab Plus Chemotherapy, Chemotherapy Alone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in percentages |
| Estimated Value | 10.98 | |
| Confidence Interval |
() 95% 3.13 to 18.68 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Panitumumab Plus Chemotherapy, Chemotherapy Alone |
|---|---|---|
| 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 | 1.69 | |
| Confidence Interval |
() 95% 1.15 to 2.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Duration of Response |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included only those subjects with a confirmed complete or partial response. |
| Arm/Group Title | Panitumumab Plus Chemotherapy | Chemotherapy Alone |
|---|---|---|
| Arm/Group Description | Consists of Panitumumab plus Cisplatin and 5-FU | Consists of Cisplatin and 5-FU |
| Measure Participants | 101 | 73 |
| Median (95% Confidence Interval) [months] |
5.6
|
5.7
|
| Title | Time to Progression |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | Panitumumab Plus Chemotherapy | Chemotherapy Alone |
|---|---|---|
| Arm/Group Description | Consists of Panitumumab plus Cisplatin and 5-FU | Consists of Cisplatin and 5-FU |
| Measure Participants | 327 | 330 |
| Median (95% Confidence Interval) [months] |
6.8
|
5.6
|
| Title | Time to Response |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Included only those subjects with a confirmed complete response or partial response. |
| Arm/Group Title | Panitumumab Plus Chemotherapy | Chemotherapy Alone |
|---|---|---|
| Arm/Group Description | Consists of Panitumumab plus Cisplatin and 5-FU | Consists of Cisplatin and 5-FU |
| Measure Participants | 101 | 73 |
| Median (Inter-Quartile Range) [months] |
1.4
|
1.5
|
| Title | Progression Free Survival |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | Panitumumab Plus Chemotherapy | Chemotherapy Alone |
|---|---|---|
| Arm/Group Description | Consists of Panitumumab plus Cisplatin and 5-FU | Consists of Cisplatin and 5-FU |
| Measure Participants | 327 | 330 |
| Median (95% Confidence Interval) [months] |
5.8
|
4.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Panitumumab Plus Chemotherapy, Chemotherapy Alone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.780 | |
| Confidence Interval |
() 95% 0.659 to 0.922 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Cox proportional hazards model stratified by IVRS randomization factors | |
Adverse Events
| 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 | ||
| Arm/Group Description | ||||
All Cause Mortality |
||||
| Panitumumab Plus Chemotherapy | Chemotherapy Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Panitumumab Plus Chemotherapy | Chemotherapy Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 157/325 (48.3%) | 139/325 (42.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 15/325 (4.6%) | 16/325 (4.9%) | ||
| Febrile bone marrow aplasia | 1/325 (0.3%) | 0/325 (0%) | ||
| Febrile neutropenia | 18/325 (5.5%) | 12/325 (3.7%) | ||
| Haematotoxicity | 0/325 (0%) | 1/325 (0.3%) | ||
| Leukopenia | 3/325 (0.9%) | 4/325 (1.2%) | ||
| Lymphadenopathy | 1/325 (0.3%) | 0/325 (0%) | ||
| Neutropenia | 11/325 (3.4%) | 14/325 (4.3%) | ||
| Pancytopenia | 3/325 (0.9%) | 0/325 (0%) | ||
| Thrombocytopenia | 8/325 (2.5%) | 4/325 (1.2%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 1/325 (0.3%) | 0/325 (0%) | ||
| Arrhythmia supraventricular | 1/325 (0.3%) | 0/325 (0%) | ||
| Atrial fibrillation | 1/325 (0.3%) | 0/325 (0%) | ||
| Bradycardia | 2/325 (0.6%) | 0/325 (0%) | ||
| Cardiac arrest | 0/325 (0%) | 4/325 (1.2%) | ||
| Cardiac failure | 3/325 (0.9%) | 0/325 (0%) | ||
| Cardiac failure acute | 1/325 (0.3%) | 0/325 (0%) | ||
| Cardio-respiratory arrest | 1/325 (0.3%) | 5/325 (1.5%) | ||
| Cardiopulmonary failure | 2/325 (0.6%) | 1/325 (0.3%) | ||
| Cardiovascular insufficiency | 0/325 (0%) | 1/325 (0.3%) | ||
| Intracardiac thrombus | 1/325 (0.3%) | 0/325 (0%) | ||
| Myocardial infarction | 1/325 (0.3%) | 0/325 (0%) | ||
| Sinus arrhythmia | 1/325 (0.3%) | 0/325 (0%) | ||
| Tachycardia | 1/325 (0.3%) | 0/325 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Ichthyosis | 1/325 (0.3%) | 0/325 (0%) | ||
| Ear and labyrinth disorders | ||||
| Hypoacusis | 1/325 (0.3%) | 0/325 (0%) | ||
| Vertigo | 0/325 (0%) | 2/325 (0.6%) | ||
| Eye disorders | ||||
| Papilloedema | 0/325 (0%) | 1/325 (0.3%) | ||
| Retinal artery occlusion | 1/325 (0.3%) | 0/325 (0%) | ||
| Vision blurred | 0/325 (0%) | 1/325 (0.3%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 0/325 (0%) | 1/325 (0.3%) | ||
| Aphagia | 1/325 (0.3%) | 0/325 (0%) | ||
| Ascites | 0/325 (0%) | 1/325 (0.3%) | ||
| Constipation | 1/325 (0.3%) | 0/325 (0%) | ||
| Diarrhoea | 9/325 (2.8%) | 4/325 (1.2%) | ||
| Diarrhoea haemorrhagic | 1/325 (0.3%) | 0/325 (0%) | ||
| Duodenal ulcer | 1/325 (0.3%) | 0/325 (0%) | ||
| Dysphagia | 3/325 (0.9%) | 7/325 (2.2%) | ||
| Faecaloma | 1/325 (0.3%) | 0/325 (0%) | ||
| Gastrointestinal haemorrhage | 1/325 (0.3%) | 0/325 (0%) | ||
| Gastrointestinal perforation | 0/325 (0%) | 1/325 (0.3%) | ||
| Gastrointestinal toxicity | 0/325 (0%) | 1/325 (0.3%) | ||
| Haematemesis | 1/325 (0.3%) | 2/325 (0.6%) | ||
| Ileus paralytic | 1/325 (0.3%) | 0/325 (0%) | ||
| Inguinal hernia, obstructive | 1/325 (0.3%) | 0/325 (0%) | ||
| Melaena | 1/325 (0.3%) | 0/325 (0%) | ||
| Mouth haemorrhage | 1/325 (0.3%) | 0/325 (0%) | ||
| Nausea | 12/325 (3.7%) | 6/325 (1.8%) | ||
| Necrotising colitis | 1/325 (0.3%) | 0/325 (0%) | ||
| Oesophagitis | 2/325 (0.6%) | 0/325 (0%) | ||
| Stomatitis | 3/325 (0.9%) | 4/325 (1.2%) | ||
| Upper gastrointestinal haemorrhage | 1/325 (0.3%) | 0/325 (0%) | ||
| Vomiting | 10/325 (3.1%) | 8/325 (2.5%) | ||
| General disorders | ||||
| Abasia | 0/325 (0%) | 1/325 (0.3%) | ||
| Asthenia | 8/325 (2.5%) | 3/325 (0.9%) | ||
| Chest pain | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Death | 2/325 (0.6%) | 2/325 (0.6%) | ||
| Device occlusion | 1/325 (0.3%) | 0/325 (0%) | ||
| Face oedema | 1/325 (0.3%) | 0/325 (0%) | ||
| Facial pain | 1/325 (0.3%) | 0/325 (0%) | ||
| Fatigue | 4/325 (1.2%) | 1/325 (0.3%) | ||
| General physical health deterioration | 10/325 (3.1%) | 9/325 (2.8%) | ||
| Hyperpyrexia | 1/325 (0.3%) | 0/325 (0%) | ||
| Hyperthermia | 1/325 (0.3%) | 0/325 (0%) | ||
| Infusion site extravasation | 0/325 (0%) | 1/325 (0.3%) | ||
| Malaise | 1/325 (0.3%) | 0/325 (0%) | ||
| Medical device complication | 0/325 (0%) | 2/325 (0.6%) | ||
| Mucosal inflammation | 5/325 (1.5%) | 7/325 (2.2%) | ||
| Multi-organ failure | 1/325 (0.3%) | 0/325 (0%) | ||
| Non-cardiac chest pain | 1/325 (0.3%) | 0/325 (0%) | ||
| Pain | 5/325 (1.5%) | 0/325 (0%) | ||
| Pyrexia | 5/325 (1.5%) | 10/325 (3.1%) | ||
| Sudden death | 1/325 (0.3%) | 2/325 (0.6%) | ||
| Thrombosis in device | 1/325 (0.3%) | 0/325 (0%) | ||
| Hepatobiliary disorders | ||||
| Hepatic failure | 1/325 (0.3%) | 0/325 (0%) | ||
| Jaundice | 1/325 (0.3%) | 0/325 (0%) | ||
| Immune system disorders | ||||
| Anaphylactic shock | 1/325 (0.3%) | 0/325 (0%) | ||
| Hypersensitivity | 2/325 (0.6%) | 0/325 (0%) | ||
| Infections and infestations | ||||
| Abscess | 2/325 (0.6%) | 0/325 (0%) | ||
| Abscess neck | 1/325 (0.3%) | 0/325 (0%) | ||
| Aspergillosis | 1/325 (0.3%) | 0/325 (0%) | ||
| Bronchiectasis | 1/325 (0.3%) | 0/325 (0%) | ||
| Bronchitis | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Bronchopneumonia | 0/325 (0%) | 2/325 (0.6%) | ||
| Campylobacter infection | 1/325 (0.3%) | 0/325 (0%) | ||
| Candidiasis | 0/325 (0%) | 1/325 (0.3%) | ||
| Catheter site infection | 2/325 (0.6%) | 0/325 (0%) | ||
| Cellulitis | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Clostridial infection | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Clostridium difficile colitis | 2/325 (0.6%) | 0/325 (0%) | ||
| Device related infection | 2/325 (0.6%) | 1/325 (0.3%) | ||
| Erysipelas | 1/325 (0.3%) | 0/325 (0%) | ||
| Escherichia infection | 1/325 (0.3%) | 0/325 (0%) | ||
| Gastroenteritis | 1/325 (0.3%) | 0/325 (0%) | ||
| H1N1 influenza | 1/325 (0.3%) | 0/325 (0%) | ||
| Herpes zoster | 0/325 (0%) | 1/325 (0.3%) | ||
| Herpes zoster ophthalmic | 0/325 (0%) | 1/325 (0.3%) | ||
| Infection | 3/325 (0.9%) | 2/325 (0.6%) | ||
| Influenza | 1/325 (0.3%) | 0/325 (0%) | ||
| Laryngotracheitis obstructive | 1/325 (0.3%) | 0/325 (0%) | ||
| Lobar pneumonia | 0/325 (0%) | 2/325 (0.6%) | ||
| Localised infection | 1/325 (0.3%) | 0/325 (0%) | ||
| Lower respiratory tract infection | 2/325 (0.6%) | 0/325 (0%) | ||
| Lung abscess | 1/325 (0.3%) | 0/325 (0%) | ||
| Lung infection | 0/325 (0%) | 1/325 (0.3%) | ||
| Lung infection pseudomonal | 1/325 (0.3%) | 0/325 (0%) | ||
| Lymphangitis | 1/325 (0.3%) | 0/325 (0%) | ||
| Myiasis | 0/325 (0%) | 1/325 (0.3%) | ||
| Neutropenic sepsis | 2/325 (0.6%) | 0/325 (0%) | ||
| Oral candidiasis | 1/325 (0.3%) | 0/325 (0%) | ||
| Parotitis | 1/325 (0.3%) | 0/325 (0%) | ||
| Pleural infection bacterial | 0/325 (0%) | 1/325 (0.3%) | ||
| Pneumonia | 10/325 (3.1%) | 13/325 (4%) | ||
| Pulmonary sepsis | 1/325 (0.3%) | 0/325 (0%) | ||
| Respiratory moniliasis | 1/325 (0.3%) | 0/325 (0%) | ||
| Respiratory tract infection | 2/325 (0.6%) | 2/325 (0.6%) | ||
| Sepsis | 7/325 (2.2%) | 5/325 (1.5%) | ||
| Septic shock | 2/325 (0.6%) | 2/325 (0.6%) | ||
| Skin infection | 1/325 (0.3%) | 0/325 (0%) | ||
| Soft tissue infection | 0/325 (0%) | 1/325 (0.3%) | ||
| Staphylococcal infection | 0/325 (0%) | 1/325 (0.3%) | ||
| Staphylococcal sepsis | 0/325 (0%) | 1/325 (0.3%) | ||
| Urinary tract infection | 0/325 (0%) | 1/325 (0.3%) | ||
| Viral infection | 1/325 (0.3%) | 0/325 (0%) | ||
| Wound infection | 0/325 (0%) | 1/325 (0.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Contrast media reaction | 1/325 (0.3%) | 0/325 (0%) | ||
| Gastrointestinal stoma complication | 1/325 (0.3%) | 0/325 (0%) | ||
| Head injury | 0/325 (0%) | 1/325 (0.3%) | ||
| Jaw fracture | 1/325 (0.3%) | 0/325 (0%) | ||
| Overdose | 0/325 (0%) | 1/325 (0.3%) | ||
| Rib fracture | 0/325 (0%) | 1/325 (0.3%) | ||
| Skin laceration | 1/325 (0.3%) | 0/325 (0%) | ||
| Spinal cord injury | 1/325 (0.3%) | 0/325 (0%) | ||
| Spinal shock | 1/325 (0.3%) | 0/325 (0%) | ||
| Therapeutic agent toxicity | 1/325 (0.3%) | 0/325 (0%) | ||
| Tibia fracture | 0/325 (0%) | 1/325 (0.3%) | ||
| Wound dehiscence | 0/325 (0%) | 1/325 (0.3%) | ||
| Investigations | ||||
| Blood creatinine increased | 0/325 (0%) | 1/325 (0.3%) | ||
| C-reactive protein increased | 0/325 (0%) | 1/325 (0.3%) | ||
| Neutrophil count decreased | 0/325 (0%) | 1/325 (0.3%) | ||
| Urine output decreased | 0/325 (0%) | 1/325 (0.3%) | ||
| Weight decreased | 4/325 (1.2%) | 1/325 (0.3%) | ||
| White blood cell count decreased | 0/325 (0%) | 1/325 (0.3%) | ||
| Metabolism and nutrition disorders | ||||
| Cachexia | 2/325 (0.6%) | 0/325 (0%) | ||
| Decreased appetite | 4/325 (1.2%) | 9/325 (2.8%) | ||
| Dehydration | 16/325 (4.9%) | 8/325 (2.5%) | ||
| Electrolyte imbalance | 0/325 (0%) | 1/325 (0.3%) | ||
| Feeding disorder | 1/325 (0.3%) | 0/325 (0%) | ||
| Hyperglycaemia | 0/325 (0%) | 2/325 (0.6%) | ||
| Hyperkalaemia | 0/325 (0%) | 1/325 (0.3%) | ||
| Hypoalbuminaemia | 0/325 (0%) | 1/325 (0.3%) | ||
| Hypocalcaemia | 2/325 (0.6%) | 2/325 (0.6%) | ||
| Hypoglycaemia | 1/325 (0.3%) | 0/325 (0%) | ||
| Hypokalaemia | 11/325 (3.4%) | 2/325 (0.6%) | ||
| Hypomagnesaemia | 5/325 (1.5%) | 2/325 (0.6%) | ||
| Hyponatraemia | 2/325 (0.6%) | 2/325 (0.6%) | ||
| Hypophagia | 0/325 (0%) | 1/325 (0.3%) | ||
| Hypophosphataemia | 0/325 (0%) | 1/325 (0.3%) | ||
| Malnutrition | 2/325 (0.6%) | 0/325 (0%) | ||
| Metabolic acidosis | 1/325 (0.3%) | 0/325 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2/325 (0.6%) | 0/325 (0%) | ||
| Fistula | 0/325 (0%) | 1/325 (0.3%) | ||
| Hypercreatinaemia | 1/325 (0.3%) | 0/325 (0%) | ||
| Myalgia | 0/325 (0%) | 1/325 (0.3%) | ||
| Neck pain | 0/325 (0%) | 1/325 (0.3%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Cancer pain | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Head and neck cancer | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Hypopharyngeal cancer | 1/325 (0.3%) | 0/325 (0%) | ||
| Infected neoplasm | 1/325 (0.3%) | 0/325 (0%) | ||
| Laryngeal cancer | 0/325 (0%) | 1/325 (0.3%) | ||
| Lip and/or oral cavity cancer | 0/325 (0%) | 2/325 (0.6%) | ||
| Metastases to central nervous system | 1/325 (0.3%) | 0/325 (0%) | ||
| Metastases to liver | 0/325 (0%) | 1/325 (0.3%) | ||
| Metastatic neoplasm | 0/325 (0%) | 1/325 (0.3%) | ||
| Neoplasm progression | 1/325 (0.3%) | 0/325 (0%) | ||
| Oropharyngeal neoplasm | 0/325 (0%) | 1/325 (0.3%) | ||
| Pharyngeal cancer stage unspecified | 0/325 (0%) | 1/325 (0.3%) | ||
| Squamous cell carcinoma | 1/325 (0.3%) | 0/325 (0%) | ||
| Tongue neoplasm malignant stage unspecified | 0/325 (0%) | 2/325 (0.6%) | ||
| Tumour associated fever | 0/325 (0%) | 1/325 (0.3%) | ||
| Tumour haemorrhage | 1/325 (0.3%) | 6/325 (1.8%) | ||
| Tumour pain | 0/325 (0%) | 1/325 (0.3%) | ||
| Nervous system disorders | ||||
| Cerebral haemorrhage | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Cerebral ischaemia | 2/325 (0.6%) | 0/325 (0%) | ||
| Cerebrovascular accident | 3/325 (0.9%) | 0/325 (0%) | ||
| Coma | 0/325 (0%) | 1/325 (0.3%) | ||
| Convulsion | 2/325 (0.6%) | 1/325 (0.3%) | ||
| Depressed level of consciousness | 0/325 (0%) | 1/325 (0.3%) | ||
| Dizziness | 1/325 (0.3%) | 3/325 (0.9%) | ||
| Encephalopathy | 0/325 (0%) | 2/325 (0.6%) | ||
| Epilepsy | 1/325 (0.3%) | 0/325 (0%) | ||
| Extrapyramidal disorder | 0/325 (0%) | 1/325 (0.3%) | ||
| Grand mal convulsion | 1/325 (0.3%) | 0/325 (0%) | ||
| Headache | 1/325 (0.3%) | 0/325 (0%) | ||
| Hemiparesis | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Ischaemic stroke | 3/325 (0.9%) | 2/325 (0.6%) | ||
| Lethargy | 1/325 (0.3%) | 0/325 (0%) | ||
| Loss of consciousness | 0/325 (0%) | 1/325 (0.3%) | ||
| Motor dysfunction | 1/325 (0.3%) | 0/325 (0%) | ||
| Neuropathy peripheral | 0/325 (0%) | 2/325 (0.6%) | ||
| Peripheral motor neuropathy | 1/325 (0.3%) | 0/325 (0%) | ||
| Presyncope | 0/325 (0%) | 1/325 (0.3%) | ||
| Radiculitis lumbosacral | 0/325 (0%) | 1/325 (0.3%) | ||
| Syncope | 3/325 (0.9%) | 1/325 (0.3%) | ||
| Transient ischaemic attack | 1/325 (0.3%) | 0/325 (0%) | ||
| Psychiatric disorders | ||||
| Agitation | 1/325 (0.3%) | 0/325 (0%) | ||
| Completed suicide | 0/325 (0%) | 1/325 (0.3%) | ||
| Confusional state | 3/325 (0.9%) | 1/325 (0.3%) | ||
| Depression | 0/325 (0%) | 1/325 (0.3%) | ||
| Mental status changes | 1/325 (0.3%) | 0/325 (0%) | ||
| Renal and urinary disorders | ||||
| Anuria | 0/325 (0%) | 1/325 (0.3%) | ||
| Nephropathy toxic | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Renal failure | 5/325 (1.5%) | 5/325 (1.5%) | ||
| Renal failure acute | 3/325 (0.9%) | 3/325 (0.9%) | ||
| Renal impairment | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Reproductive system and breast disorders | ||||
| Benign prostatic hyperplasia | 1/325 (0.3%) | 0/325 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Anoxia | 1/325 (0.3%) | 0/325 (0%) | ||
| Apnoea | 0/325 (0%) | 1/325 (0.3%) | ||
| Asphyxia | 2/325 (0.6%) | 1/325 (0.3%) | ||
| Aspiration | 1/325 (0.3%) | 0/325 (0%) | ||
| Bronchopneumopathy | 1/325 (0.3%) | 0/325 (0%) | ||
| Chronic obstructive pulmonary disease | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Dyspnoea | 1/325 (0.3%) | 3/325 (0.9%) | ||
| Epistaxis | 0/325 (0%) | 1/325 (0.3%) | ||
| Haemoptysis | 0/325 (0%) | 1/325 (0.3%) | ||
| Hypoxia | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Increased viscosity of bronchial secretion | 0/325 (0%) | 1/325 (0.3%) | ||
| Laryngeal dyspnoea | 0/325 (0%) | 1/325 (0.3%) | ||
| Lung disorder | 1/325 (0.3%) | 0/325 (0%) | ||
| Obstructive airways disorder | 1/325 (0.3%) | 0/325 (0%) | ||
| Pneumonia aspiration | 5/325 (1.5%) | 4/325 (1.2%) | ||
| Pneumonitis | 1/325 (0.3%) | 2/325 (0.6%) | ||
| Pneumothorax | 3/325 (0.9%) | 0/325 (0%) | ||
| Productive cough | 1/325 (0.3%) | 0/325 (0%) | ||
| Pulmonary embolism | 3/325 (0.9%) | 3/325 (0.9%) | ||
| Pulmonary haemorrhage | 0/325 (0%) | 1/325 (0.3%) | ||
| Pulmonary oedema | 1/325 (0.3%) | 0/325 (0%) | ||
| Respiratory disorder | 0/325 (0%) | 1/325 (0.3%) | ||
| Respiratory distress | 2/325 (0.6%) | 0/325 (0%) | ||
| Respiratory failure | 1/325 (0.3%) | 3/325 (0.9%) | ||
| Respiratory tract haemorrhage | 0/325 (0%) | 1/325 (0.3%) | ||
| Tracheal stenosis | 1/325 (0.3%) | 0/325 (0%) | ||
| Upper airway obstruction | 1/325 (0.3%) | 0/325 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis acneiform | 1/325 (0.3%) | 0/325 (0%) | ||
| Palmar-plantar erythrodysaesthesia syndrome | 0/325 (0%) | 1/325 (0.3%) | ||
| Psoriasis | 1/325 (0.3%) | 0/325 (0%) | ||
| Rash | 3/325 (0.9%) | 0/325 (0%) | ||
| Skin disorder | 1/325 (0.3%) | 1/325 (0.3%) | ||
| Skin ulcer | 1/325 (0.3%) | 0/325 (0%) | ||
| Vascular disorders | ||||
| Circulatory collapse | 1/325 (0.3%) | 0/325 (0%) | ||
| Deep vein thrombosis | 4/325 (1.2%) | 0/325 (0%) | ||
| Haemorrhage | 2/325 (0.6%) | 0/325 (0%) | ||
| Hypertension | 1/325 (0.3%) | 0/325 (0%) | ||
| Hypertensive crisis | 1/325 (0.3%) | 0/325 (0%) | ||
| Hypotension | 7/325 (2.2%) | 2/325 (0.6%) | ||
| Hypovolaemic shock | 1/325 (0.3%) | 0/325 (0%) | ||
| Iliac artery embolism | 1/325 (0.3%) | 0/325 (0%) | ||
| Infarction | 1/325 (0.3%) | 0/325 (0%) | ||
| Jugular vein thrombosis | 1/325 (0.3%) | 0/325 (0%) | ||
| Orthostatic hypotension | 0/325 (0%) | 2/325 (0.6%) | ||
| Peripheral arterial occlusive disease | 1/325 (0.3%) | 0/325 (0%) | ||
| Phlebitis | 1/325 (0.3%) | 0/325 (0%) | ||
| Thrombosis | 3/325 (0.9%) | 1/325 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Panitumumab Plus Chemotherapy | Chemotherapy Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 311/325 (95.7%) | 301/325 (92.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 132/325 (40.6%) | 126/325 (38.8%) | ||
| Leukopenia | 51/325 (15.7%) | 49/325 (15.1%) | ||
| Neutropenia | 157/325 (48.3%) | 140/325 (43.1%) | ||
| Thrombocytopenia | 74/325 (22.8%) | 74/325 (22.8%) | ||
| Ear and labyrinth disorders | ||||
| Tinnitus | 21/325 (6.5%) | 28/325 (8.6%) | ||
| Eye disorders | ||||
| Conjunctivitis | 23/325 (7.1%) | 4/325 (1.2%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 20/325 (6.2%) | 10/325 (3.1%) | ||
| Abdominal pain upper | 22/325 (6.8%) | 18/325 (5.5%) | ||
| Constipation | 83/325 (25.5%) | 74/325 (22.8%) | ||
| Diarrhoea | 123/325 (37.8%) | 76/325 (23.4%) | ||
| Dyspepsia | 25/325 (7.7%) | 20/325 (6.2%) | ||
| Dysphagia | 23/325 (7.1%) | 24/325 (7.4%) | ||
| Nausea | 178/325 (54.8%) | 180/325 (55.4%) | ||
| Stomatitis | 67/325 (20.6%) | 62/325 (19.1%) | ||
| Vomiting | 140/325 (43.1%) | 126/325 (38.8%) | ||
| General disorders | ||||
| Asthenia | 65/325 (20%) | 54/325 (16.6%) | ||
| Fatigue | 90/325 (27.7%) | 81/325 (24.9%) | ||
| Mucosal inflammation | 71/325 (21.8%) | 62/325 (19.1%) | ||
| Oedema peripheral | 21/325 (6.5%) | 22/325 (6.8%) | ||
| Pyrexia | 50/325 (15.4%) | 45/325 (13.8%) | ||
| Infections and infestations | ||||
| Paronychia | 36/325 (11.1%) | 1/325 (0.3%) | ||
| Investigations | ||||
| Blood creatinine increased | 23/325 (7.1%) | 33/325 (10.2%) | ||
| Weight decreased | 81/325 (24.9%) | 54/325 (16.6%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 94/325 (28.9%) | 90/325 (27.7%) | ||
| Hypocalcaemia | 42/325 (12.9%) | 20/325 (6.2%) | ||
| Hypokalaemia | 47/325 (14.5%) | 43/325 (13.2%) | ||
| Hypomagnesaemia | 132/325 (40.6%) | 66/325 (20.3%) | ||
| Hyponatraemia | 26/325 (8%) | 16/325 (4.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Neck pain | 15/325 (4.6%) | 20/325 (6.2%) | ||
| Nervous system disorders | ||||
| Dizziness | 28/325 (8.6%) | 21/325 (6.5%) | ||
| Headache | 29/325 (8.9%) | 35/325 (10.8%) | ||
| Neuropathy peripheral | 27/325 (8.3%) | 20/325 (6.2%) | ||
| Psychiatric disorders | ||||
| Insomnia | 27/325 (8.3%) | 21/325 (6.5%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 41/325 (12.6%) | 30/325 (9.2%) | ||
| Dyspnoea | 31/325 (9.5%) | 19/325 (5.8%) | ||
| Oropharyngeal pain | 11/325 (3.4%) | 19/325 (5.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 27/325 (8.3%) | 3/325 (0.9%) | ||
| Alopecia | 49/325 (15.1%) | 36/325 (11.1%) | ||
| Dermatitis acneiform | 48/325 (14.8%) | 0/325 (0%) | ||
| Dry skin | 45/325 (13.8%) | 4/325 (1.2%) | ||
| Erythema | 26/325 (8%) | 3/325 (0.9%) | ||
| Pruritus | 47/325 (14.5%) | 5/325 (1.5%) | ||
| Rash | 165/325 (50.8%) | 9/325 (2.8%) | ||
| Skin fissures | 24/325 (7.4%) | 0/325 (0%) | ||
| Vascular disorders | ||||
| Hypertension | 16/325 (4.9%) | 19/325 (5.8%) | ||
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 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
Other Study ID Numbers:
- 20050251
First Posted:
Apr 13, 2007
Last Update Posted:
Mar 7, 2014
Last Verified:
Feb 1, 2014