TriangleNCT00939627 · STUDY IN CONTEXT
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
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.
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.
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)
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
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.
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.
Reported safety
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- 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