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Clinical Trial Summary

This phase I trial is studying the side effects of gefitinib in treating patients with metastatic or unresectable head and neck cancer or non-small cell lung cancer. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for their growth


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the feasibility of enrolling patients ages 75 years or older and 50 years and younger with metastatic or unresectable head and neck cancer or non-small cell lung cancer, to a structured pilot study that includes pharmacokinetic sampling in a special patient population.

II. To preliminarily compare the ZD-1839 peak concentration level, elimination half-life and steady state level between the two patient age groups.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to age (75 years and over vs 50 years and under)

Patients receive oral gefitinib on day 1 and then daily beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days and then for up to 3 years after study registration. ;


Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Anaplastic Thyroid Cancer
  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Carcinoma, Basal Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Esthesioneuroblastoma, Olfactory
  • Granuloma
  • Head and Neck Neoplasms
  • Insular Thyroid Cancer
  • Laryngeal Diseases
  • Laryngeal Neoplasms
  • Lung Neoplasms
  • Metastatic Parathyroid Cancer
  • Nasopharyngeal Neoplasms
  • Oropharyngeal Neoplasms
  • Papilloma
  • Paranasal Sinus Neoplasms
  • Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
  • Recurrent Basal Cell Carcinoma of the Lip
  • 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 Non-small Cell Lung Cancer
  • Recurrent Parathyroid Cancer
  • 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 Thyroid Cancer
  • Recurrent Verrucous Carcinoma of the Larynx
  • Salivary Gland Neoplasms
  • Stage III Follicular Thyroid Cancer
  • Stage III Papillary Thyroid Cancer
  • Stage III Salivary Gland Cancer
  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage III Verrucous Carcinoma of the Larynx
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Lymphoepithelioma of the Nasopharynx
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Nasopharynx
  • Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IVA Basal Cell Carcinoma of the Lip
  • Stage IVA Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Follicular Thyroid Cancer
  • Stage IVA Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Lymphoepithelioma of the Oropharynx
  • Stage IVA Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage IVA Papillary Thyroid Cancer
  • Stage IVA Salivary Gland Cancer
  • Stage IVA Squamous Cell Carcinoma of the Larynx
  • Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVA Squamous Cell Carcinoma of the Oropharynx
  • Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVA Verrucous Carcinoma of the Larynx
  • Stage IVA Verrucous Carcinoma of the Oral Cavity
  • Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IVB Basal Cell Carcinoma of the Lip
  • Stage IVB Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVB Follicular Thyroid Cancer
  • Stage IVB Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
  • Stage IVB Lymphoepithelioma of the Oropharynx
  • Stage IVB Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
  • Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage IVB Papillary Thyroid Cancer
  • Stage IVB Salivary Gland Cancer
  • Stage IVB Squamous Cell Carcinoma of the Larynx
  • Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Oropharynx
  • Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVB Verrucous Carcinoma of the Larynx
  • Stage IVB Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IVC Basal Cell Carcinoma of the Lip
  • Stage IVC Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Follicular Thyroid Cancer
  • Stage IVC Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Lymphoepithelioma of the Oropharynx
  • Stage IVC Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage IVC Papillary Thyroid Cancer
  • Stage IVC Salivary Gland Cancer
  • Stage IVC Squamous Cell Carcinoma of the Larynx
  • Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Oropharynx
  • Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
  • Stage IVC Verrucous Carcinoma of the Larynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Thryoid Gland Nonmedullary Carcinoma
  • Thyroid Diseases
  • Thyroid Gland Medullary Carcinoma
  • Thyroid Neoplasms
  • Tongue Cancer
  • Untreated Metastatic Squamous Neck Cancer With Occult Primary

NCT number NCT00068497
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase N/A
Start date August 2003

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