# Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer

> **NCT00397384** · PHASE1 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 43 (actual)

## Conditions studied

- 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

- **DRUG:** cetuximab
- **DRUG:** erlotinib hydrochloride
- **OTHER:** laboratory biomarker analysis

## Key facts

- **NCT ID:** NCT00397384
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-01
- **Primary completion:** 2013-06
- **Final completion:** 2013-06
- **Target enrollment:** 43 (ACTUAL)
- **Last updated:** 2015-09-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00397384

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00397384, "Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT00397384. Licensed CC0.

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