Trial · NCT01256385
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
NCT01256385, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy. Trials, record NCT01256385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256385
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
- NCT number
- NCT01256385
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 86 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Squamous Cell Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage IV Hypopharyngeal Squamous Cell Carcinoma, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVA Laryngeal Squamous Cell Carcinoma, Stage IVA Laryngeal Verrucous Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Major Salivary Gland Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVA Oral Cavity Verrucous Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Laryngeal Squamous Cell Carcinoma, Stage IVB Laryngeal Verrucous Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Major Salivary Gland Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Oral Cavity Verrucous Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Laryngeal Squamous Cell Carcinoma, Stage IVC Laryngeal Verrucous Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Major Salivary Gland Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Oral Cavity Verrucous Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Tongue Carcinoma
- Interventions
- Cetuximab, Laboratory Biomarker Analysis, Temsirolimus
- First posted
- 2010-12-08
- Last updated
- 2017-03-27
- Results first posted
- 2017-02-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From start of treatment to time of progression or death from any cause, assessed up to 5 years | 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. |
| Secondary | Overall Survival (OS) | Up to 5 years | Time from randomization until death from any cause |
| Secondary | Overall Response Rates (OR) | Up to 5 years | 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. |
| Secondary | PFS vs. Historical Control Cohort | From start of treatment to time of progression or death of any cause, assessed at 4 months | 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. |
| Secondary | Grade 3 or Higher Hematological Toxicity | Up to 5 years | Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4 |
| Secondary | Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST | Up to 5 years | 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. |
| Secondary | PFS of Myofibroblast (+) Cohort | From start of treatment to time of progression or death of any cause, assessed up to 5 years | |
| Secondary | Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B. | Up to 5 years | Assessed according to RECIST. This is includes complete and partial responses as well as stable disease, and is different from Outcome Measure 6 above, which includes only complete and partial responses. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | From start of treatment to time of progression or death from any cause, assessed up to 5 years | days | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Up to 5 years | days | MEDIAN | |
| SECONDARY | Overall Response Rates (OR) | Up to 5 years | percentage of participants | NUMBER | |
| SECONDARY | PFS vs. Historical Control Cohort | From start of treatment to time of progression or death of any cause, assessed at 4 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Grade 3 or Higher Hematological Toxicity | Up to 5 years | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST | Up to 5 years | percentage of participants | NUMBER | |
| SECONDARY | PFS of Myofibroblast (+) Cohort | From start of treatment to time of progression or death of any cause, assessed up to 5 years | Myofibroblast status was not determined. Concerns about the validity/technical feasibility as well as availability of the assay led us to decide to not perform the assay. We do not intend to perform this assay anymore. | ||
| SECONDARY | Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B. | Up to 5 years | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Arm A (Cetuximab and Temsirolimus) | 105 | 95% Confidence Interval 70 to 136 | days | |
| Progression-free Survival (PFS) | Arm B (Temsirolimus) | 105 | 95% Confidence Interval 77 to 147 | days | |
| Overall Survival (OS) | Arm A (Cetuximab and Temsirolimus) | 177 | 95% Confidence Interval 146 to 247 | days | |
| Overall Survival (OS) | Arm B (Temsirolimus) | 176 | 95% Confidence Interval 131 to 316 | days | |
| Overall Response Rates (OR) | Arm A (Cetuximab and Temsirolimus) | 12.5 | 95% Confidence Interval 4.2 to 26.8 | percentage of participants | |
| Overall Response Rates (OR) | Arm B (Temsirolimus) | 2.5 | 95% Confidence Interval 0.1 to 13.2 | percentage of participants | |
| PFS vs. Historical Control Cohort | Arm A (Cetuximab and Temsirolimus) | 41.3 | 90% Confidence Interval 28.3 to 54.3 | percentage of participants | |
| PFS vs. Historical Control Cohort | Arm B (Temsirolimus) | 36.4 | 90% Confidence Interval 22.6 to 50.2 | percentage of participants | |
| Grade 3 or Higher Hematological Toxicity | Arm A (Cetuximab and Temsirolimus) | 17.5 | 95% Confidence Interval 7.3 to 32.8 | percentage of participants | |
| Grade 3 or Higher Hematological Toxicity | Arm B (Temsirolimus) | 25 | 95% Confidence Interval 12.7 to 41.1 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Cetuximab and Temsirolimus) | 43 | |
| Overall Study | STARTED | Arm B (Temsirolimus) | 43 | |
| Overall Study | Crossover From Arm B to Arm A | Arm A (Cetuximab and Temsirolimus) | 0 | |
| Overall Study | Crossover From Arm B to Arm A | Arm B (Temsirolimus) | 15 | |
| Overall Study | COMPLETED | Arm A (Cetuximab and Temsirolimus) | 40 | |
| Overall Study | COMPLETED | Arm B (Temsirolimus) | 40 | |
| Overall Study | NOT COMPLETED | Arm A (Cetuximab and Temsirolimus) | 3 | |
| Overall Study | NOT COMPLETED | Arm B (Temsirolimus) | 3 |
Source ClinicalTrials.gov
Adverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Arm A (Cetuximab and Temsirolimus) | 11 | 40 | |
| other | Alanine aminotransferase increased | Investigations | Arm B (Temsirolimus) | 10 | 40 | |
| other | Alkaline phosphatase increased | Investigations | Arm A (Cetuximab and Temsirolimus) | 10 | 40 | |
| other | Alkaline phosphatase increased | Investigations | Arm B (Temsirolimus) | 7 | 40 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm A (Cetuximab and Temsirolimus) | 2 | 40 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm B (Temsirolimus) | 2 | 40 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm A (Cetuximab and Temsirolimus) | 3 | 40 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Arm B (Temsirolimus) | 1 | 40 | |
| other | Anemia | Blood and lymphatic system disorders | Arm A (Cetuximab and Temsirolimus) | 24 | 40 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Temsirolimus) | 26 | 40 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Cetuximab and Temsirolimus) | ||
| Total, all-cause mortality | Arm B (Temsirolimus) | ||
| Total, other adverse events | Arm A (Cetuximab and Temsirolimus) | 39 | 40 |
| Total, other adverse events | Arm B (Temsirolimus) | 37 | 40 |
| Total, serious adverse events | Arm A (Cetuximab and Temsirolimus) | 14 | 40 |
| Total, serious adverse events | Arm B (Temsirolimus) | 19 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA014599 | Cancer Center Support Grant | ODUNSI, KUNLE | UNIVERSITY OF CHICAGO | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A (Cetuximab and Temsirolimus) vs Arm B (Temsirolimus): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01256385
GET https://conductscience.org/api/trials/v1/NCT01256385/events?page=2