NCT01256385 · STUDY IN CONTEXT

Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Progression determined using RECIST criteria: \>=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.

Source null

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secondary · POSTED

Time from randomization until death from any cause

Source null

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secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Statistics reported are for Overall Response (OR) = CR + PR.

Source null

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secondary · POSTED

PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.

Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.

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secondary · POSTED

Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4

Source null

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secondary · POSTED

Percentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively. This is includes complete and partial responses, and is different from Outcome Measure 8 below, which includes complete and partial responses as well as stable disease.

Source null

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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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-salivary-gland-cancer-recurrent-79ac7906
nct id: NCT01256385
trial label: Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0000
source section id
NCT01256385-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS)
endpoint definition
Progression determined using RECIST criteria: \>=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.
time origin
From start of treatment to time of progression or death from any cause, assessed up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0001
source section id
NCT01256385-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
Time from randomization until death from any cause
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0002
source section id
NCT01256385-om-0002
source outcome index
2
endpoint
Overall Response Rates (OR)
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Statistics reported are for Overall Response (OR) = CR + PR.
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0003
source section id
NCT01256385-om-0003
source outcome index
3
endpoint
PFS vs. Historical Control Cohort
endpoint definition
PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.
time origin
From start of treatment to time of progression or death of any cause, assessed at 4 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0004
source section id
NCT01256385-om-0004
source outcome index
4
endpoint
Grade 3 or Higher Hematological Toxicity
endpoint definition
Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0005
source section id
NCT01256385-om-0005
source outcome index
5
endpoint
Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST
endpoint definition
Percentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively. This is includes complete and partial responses, and is different from Outcome Measure 8 below, which includes complete and partial responses as well as stable disease.
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0000
arm key
OG000
arm label
Arm A (Cetuximab and Temsirolimus)
regimen
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0000
arm key
OG001
arm label
Arm B (Temsirolimus)
regimen
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0001
arm key
OG000
arm label
Arm A (Cetuximab and Temsirolimus)
regimen
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0001
arm key
OG001
arm label
Arm B (Temsirolimus)
regimen
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0002
arm key
OG000
arm label
Arm A (Cetuximab and Temsirolimus)
regimen
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0002
arm key
OG001
arm label
Arm B (Temsirolimus)
regimen
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0003
arm key
OG000
arm label
Arm A (Cetuximab and Temsirolimus)
regimen
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0003
arm key
OG001
arm label
Arm B (Temsirolimus)
regimen
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0004
arm key
OG000
arm label
Arm A (Cetuximab and Temsirolimus)
regimen
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0004
arm key
OG001
arm label
Arm B (Temsirolimus)
regimen
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0005
arm key
OG000
arm label
Arm A (Cetuximab and Temsirolimus)
regimen
Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
outcome key
om-0005
arm key
OG001
arm label
Arm B (Temsirolimus)
regimen
Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01256385-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
harm key
EG000
source section id
NCT01256385-ae
event group key
EG000
event group label
Arm A (Cetuximab and Temsirolimus)
serious affected
14
serious at risk
40
other affected
39
other at risk
40
frequency threshold
5
collection period
Source null
event definition
Source null
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-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT01256385
harm key
EG001
source section id
NCT01256385-ae
event group key
EG001
event group label
Arm B (Temsirolimus)
serious affected
19
serious at risk
40
other affected
37
other at risk
40
frequency threshold
5
collection period
Source null
event definition
Source null
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

setting source links

Preserved source evidence · Not medical advice