ClinicalTrials.gov record
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
ClinicalTrials.gov ID: NCT01256385
Public ClinicalTrials.gov record NCT01256385. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 20, 2026, 2:30 AM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A T1 Translational Multicenter Randomized Phase II Study of Temsirolimus Versus Cetuximab Plus Temsirolimus in Patients With Recurrent / Metastatic Head and Neck Cancer, Who Failed Prior EGFR Based Therapy
Study identification
- NCT ID
- NCT01256385
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- Enrollment
- 86 participants
Conditions and interventions
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 Biological
- Laboratory Biomarker Analysis Other
- Temsirolimus Drug
Biological · Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2010
- Primary completion
- Nov 30, 2013
- Completion
- Nov 30, 2013
- Last update posted
- Mar 26, 2017
2010 – 2013
United States locations
- U.S. sites
- 23
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | — |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62702 | — |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | — |
| Fort Wayne Medical Oncology and Hematology Inc-Parkview | Fort Wayne | Indiana | 46845 | — |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01256385, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2017 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01256385 live on ClinicalTrials.gov.