Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.

All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.

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secondary · POSTED

Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.

All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.

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secondary · POSTED

Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)

All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.

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secondary · POSTED

Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death

Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.

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secondary · POSTED

Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when \>70% cells stained, otherwise negative) were to be described using frequencies.

Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.

→

secondary · POSTED

Twelve immunomodulatory cytokines were selected based on previous a feasibility study and detected using multiplex Luminex bead assays from patient's plasma. One cytokines, HGF, was eliminated due to extremely low expression. Three representative cytokines, TGF-beta 1, IL-8 and VEGF were to be evaluated for association with survival due to clustering.

Data were not collected due to an insufficient amount of tumor tissue available.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Unnamed quality-of-life measure · Quality of Life

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id: NCT00939627
qol key: qol-0006
source section id: NCT00939627-om-0006
source outcome index: 6
instrument: Unnamed quality-of-life measure
instrument basis: matched 'quality of life' in the study's own wording
scale title: Quality of Life
measure definition: Quality of Life Survey results.
time frame: up to 3 years
analysis role: exploratory
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Data were not collected as The Quality of Life survey instrument was not completed by study participants..
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id: NCT00939627
trial label: Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 1

outcomes

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0000
source section id
NCT00939627-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS)
endpoint definition
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
time origin
On-study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known alive date.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0001
source section id
NCT00939627-om-0001
source outcome index
1
endpoint
Best Response
endpoint definition
Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.
time origin
On-treatment date to date of disease progression (assessed up to 3 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0002
source section id
NCT00939627-om-0002
source outcome index
2
endpoint
Overall Survival (OS)
endpoint definition
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)
time origin
On-study date to date of death from any cause (assessed up to 3 years)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0003
source section id
NCT00939627-om-0003
source outcome index
3
endpoint
Number of Participants With Each Worst-Grade Toxicity
endpoint definition
Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death
time origin
On-study date to 30 days following final dose of study drug
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0004
source section id
NCT00939627-om-0004
source outcome index
4
endpoint
Gene Expression Levels
endpoint definition
Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when \>70% cells stained, otherwise negative) were to be described using frequencies.
time origin
Pre-therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0005
source section id
NCT00939627-om-0005
source outcome index
5
endpoint
Overall Survival Associated With Immunomodulatory Cytokines
endpoint definition
Twelve immunomodulatory cytokines were selected based on previous a feasibility study and detected using multiplex Luminex bead assays from patient's plasma. One cytokines, HGF, was eliminated due to extremely low expression. Three representative cytokines, TGF-beta 1, IL-8 and VEGF were to be evaluated for association with survival due to clustering.
time origin
Pre-therapy, up to about 42 months (follow-up for overall survival)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected due to an insufficient amount of tumor tissue available.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0000
arm key
OG000
arm label
Arm A - Cetuximab
regimen
Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0000
arm key
OG001
arm label
Arm B - Cetuximab and Sorafenib Tosylate
regimen
Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0001
arm key
OG000
arm label
Arm A - Cetuximab
regimen
Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0001
arm key
OG001
arm label
Arm B - Cetuximab and Sorafenib Tosylate
regimen
Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0002
arm key
OG000
arm label
Arm A - Cetuximab
regimen
Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0002
arm key
OG001
arm label
Arm B - Cetuximab and Sorafenib Tosylate
regimen
Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0003
arm key
OG000
arm label
Arm A - Cetuximab
regimen
Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0003
arm key
OG001
arm label
Arm B - Cetuximab and Sorafenib Tosylate
regimen
Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0004
arm key
OG000
arm label
Arm A - Cetuximab
regimen
Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0004
arm key
OG001
arm label
Arm B - Cetuximab and Sorafenib Tosylate
regimen
Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0005
arm key
OG000
arm label
Arm A - Cetuximab
regimen
Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
outcome key
om-0005
arm key
OG001
arm label
Arm B - Cetuximab and Sorafenib Tosylate
regimen
Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00939627-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
harm key
EG000
source section id
NCT00939627-ae
event group key
EG000
event group label
Arm A - Cetuximab
serious affected
5
serious at risk
26
other affected
25
other at risk
26
frequency threshold
0
collection period
2 years, 4 months
event definition
All participants who received treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
harm key
EG001
source section id
NCT00939627-ae
event group key
EG001
event group label
Arm B - Cetuximab and Sorafenib Tosylate
serious affected
10
serious at risk
27
other affected
27
other at risk
27
frequency threshold
0
collection period
2 years, 4 months
event definition
All participants who received treatment.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary
nct id
NCT00939627
qol key
qol-0006
source section id
NCT00939627-om-0006
source outcome index
6
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life
measure definition
Quality of Life Survey results.
time frame
up to 3 years
analysis role
exploratory
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Data were not collected as The Quality of Life survey instrument was not completed by study participants..
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice