Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
NCT01637194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2012-07-11
Summary
This phase I trial studies the side effects and best dose of cetuximab when given together with everolimus in treating patients with metastatic or recurrent colon cancer or head and neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus may be an effective treatment for colon cancer or head and neck cancer
Conditions
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Colon Cancer
- Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Lymphoepithelioma of the Nasopharynx
- Recurrent Lymphoepithelioma of the Oropharynx
- Recurrent Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Salivary Gland Cancer
- Recurrent Squamous Cell Carcinoma of the Hypopharynx
- Recurrent Squamous Cell Carcinoma of the Larynx
- Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- Recurrent Squamous Cell Carcinoma of the Oropharynx
- Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Verrucous Carcinoma of the Larynx
- Recurrent Verrucous Carcinoma of the Oral Cavity
- Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IV Basal Cell Carcinoma of the Lip
- Stage IV Lymphoepithelioma of the Nasopharynx
- Stage IV Lymphoepithelioma of the Oropharynx
- Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Larynx
- Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Nasopharynx
- Stage IV Squamous Cell Carcinoma of the Oropharynx
- Stage IV Verrucous Carcinoma of the Larynx
- Stage IV Verrucous Carcinoma of the Oral Cavity
- Stage IVA Colon Cancer
- Stage IVA Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IVA Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IVA Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage IVA Salivary Gland Cancer
- Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage IVB Colon Cancer
- Stage IVB Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IVB Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IVB Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage IVB Salivary Gland Cancer
- Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Salivary Gland Cancer
- Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Tongue Cancer
Interventions
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
- OTHER
-
pharmacological study
Correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fox Chase Cancer Center
lead OTHER
Principal Investigators
-
Barbara Burtness · Fox Chase Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2011-07-31
- Completion
- 2011-07-31
Countries
- United States
Study Locations
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