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

> **NCT01256385** · PHASE2 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 86 (actual)

## Conditions studied

- 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

- **BIOLOGICAL:** Cetuximab
- **OTHER:** Laboratory Biomarker Analysis
- **DRUG:** Temsirolimus

## Key facts

- **NCT ID:** NCT01256385
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-11
- **Primary completion:** 2013-12
- **Final completion:** 2013-12
- **Target enrollment:** 86 (ACTUAL)
- **Last updated:** 2017-03-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01256385

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01256385, "Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT01256385. Licensed CC0.

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