Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer
Public ClinicalTrials.gov record NCT00397384. 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 Phase I Clinical and Biological Evaluation of Combined EGFR Blockade With Erlotinib and Cetuximab in Patients With Advanced Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell lung cancer, or colorectal cancer. Erlotinib hydrochloride 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. Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells.
Study identification
- NCT ID
- NCT00397384
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 43 participants
Conditions and interventions
Conditions
- Adenocarcinoma of the Colon
- Adenocarcinoma of the Rectum
- Advanced Adult Primary Liver Cancer
- Carcinoma of the Appendix
- Gastrointestinal Stromal Tumor
- Metastatic Gastrointestinal Carcinoid Tumor
- Metastatic Squamous Neck Cancer With Occult Primary
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Adult Primary Liver Cancer
- Recurrent Anal Cancer
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Colon Cancer
- Recurrent Esophageal Cancer
- Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Extrahepatic Bile Duct Cancer
- Recurrent Gallbladder Cancer
- Recurrent Gastric Cancer
- Recurrent Gastrointestinal Carcinoid Tumor
- 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 Non-small Cell Lung Cancer
- Recurrent Pancreatic Cancer
- Recurrent Rectal Cancer
- Recurrent Salivary Gland Cancer
- Recurrent Small Intestine 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
- Small Intestine Adenocarcinoma
- Small Intestine Leiomyosarcoma
- Small Intestine Lymphoma
- Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IV Anal Cancer
- Stage IV Basal Cell Carcinoma of the Lip
- Stage IV Colon Cancer
- Stage IV Esophageal Cancer
- Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IV Gastric Cancer
- Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IV Lymphoepithelioma of the Nasopharynx
- Stage IV Lymphoepithelioma of the Oropharynx
- Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage IV Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IV Non-small Cell Lung Cancer
- Stage IV Pancreatic Cancer
- Stage IV Rectal Cancer
- Stage IV Salivary Gland Cancer
- 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 Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Stage IV Verrucous Carcinoma of the Larynx
- Stage IV Verrucous Carcinoma of the Oral Cavity
- Tongue Cancer
- Unresectable Extrahepatic Bile Duct Cancer
- Unresectable Gallbladder Cancer
Interventions
- cetuximab Drug
- erlotinib hydrochloride Drug
- laboratory biomarker analysis Other
Drug · Other
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
- Dec 31, 2006
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
- Last update posted
- Sep 29, 2015
2007 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00397384, 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 Sep 29, 2015 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00397384 live on ClinicalTrials.gov.