Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving temsirolimus together with cetuximab is more effective than giving temsirolimus alone.
Study identification
- NCT ID
- NCT01256385
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- 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
- Nov 2010 (Type not available)
- Primary completion
- Dec 2013 (Actual)
- Completion
- Dec 2013 (Actual)
- Last update posted
- Mar 27, 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 27, 2017 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01256385 live on ClinicalTrials.gov.