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Completed

NCT Number: NCT00068497

Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer

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

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Key information

Conditions

Anaplastic Thyroid Cancer Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Medullary Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Cranial Nerve Diseases Endocrine Gland Neoplasms Endocrine System Diseases Esthesioneuroblastoma, Olfactory Head and Neck Neoplasms Insular Thyroid Cancer Lung Diseases Lung Neoplasms Metastatic Parathyroid Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Neuroendocrine Tumors Olfactory Nerve Diseases Parathyroid Diseases Parathyroid 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 Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Squamous Cell Carcinoma of Head and Neck 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 Stomatognathic Diseases Thoracic Neoplasms Thryoid Gland Nonmedullary Carcinoma Thyroid Cancer, Papillary Thyroid Carcinoma, Anaplastic Thyroid Diseases Thyroid Gland Medullary Carcinoma Thyroid Neoplasms Tongue Cancer Tongue Diseases Tongue Neoplasms Untreated Metastatic Squamous Neck Cancer With Occult Primary

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southwest Oncology Group

San Antonio, Texas, 78245, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer which is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective or are likely to be as effective as ZD1839; patients with known brain metastases are only eligible if their brain metastases have been treated and if in the opinion of the treating physician they are stable
  • Patients must be 75 years or older, or 50 years of age or younger
  • Serum creatinine =< the institutional upper limit of normal
  • Bilirubin =< the institutional upper limit of normal
  • SGOT or SGPT =< 2.5 x the institutional upper limit of normal; SGOT and SGPT could be =< 5 x the upper limit of normal if the patient has liver metastases as long as the bilirubin is normal
  • AGC of >= 1,500/ul
  • Platelet count of >= 100,000/ul
  • Patients requiring agents that induce CYP3A4 are excluded from the study, at the present time, agents known to induce CYP3A4 include the antibiotics nafcillin and rifampin, the anticonvulsants carbamazepine, phenobarbital, phenytoin, oxcarbazepine, fosphenytoin and primidone as well as St. John's Wort, rifabutin, rifapentine and modafinil
  • Patients may or may not have received prior chemotherapy; patients must not have a curative option and in the opinion of the treating physician there is no other treatment option likely to provide greater benefit; patients must not have received prior treatment with EGFR inhibitors; patients must have recovered from the effects of prior therapy; all prior therapies must be documented
  • Patients must have a performance status of 0-2 by Zubrod standards
  • Patients must not be planning to receive concurrent radiation therapy, hormone therapy, chemotherapy or immune therapy for malignancy while receiving protocol treatment
  • Patients must agree to undergo pharmacokinetic sampling and sample submission
  • Patients known to be HIV positive and receiving retroviral therapies are not eligible
  • Patients with any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac or infection) are not eligible
  • Patients must be able to swallow oral medication in pill form; patients may not receive study medication through a feeding tube
  • A baseline slit lamp examination is NOT required; however, patients with eye symptoms (eye pain, tearing, redness, vision problems) or known eye disorders should be evaluated by an ophthalmologist/optometrist prior to registration and the results documented on the toxicity form in the notes section
  • Patients must not be pregnant or nursing; patients of reproductive potential must have agreed to use an effective contraceptive method
  • If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
  • In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding guidelines
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Treatment and study plan

Gefitinib

Drug

Given orally

Other names: Iressa, ZD 1839

Primary outcomes

  1. Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting

    Time frame: 1 year

  2. Peak ZD1839 concentration level

    Time frame: Up to 3 years

  3. Elimination half-life

    Time frame: Up to 3 years

  4. Toxicity rates between the two age groups by CTCAE version 3.0

    Time frame: Up to 3 years

  5. Responses observed

    Time frame: Up to 3 years

    Will be reported separately for the two tumor types, i.e., head and neck vs. lung cancer, with 95% confidence intervals for the estimated response rates.

  6. Survival for each tumor type

    Time frame: Up to 3 years

    Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Single Agent ZD-1839 (NSC-715055, IND-61187) in Patients With Advanced Head and Neck Carcinoma or Non-Small Cell Lung Cancer Aged 75 Years and Older (and in a Cohort of Patients 50 Years Old and Younger)

Important dates

Study start
2003
Primary completion
2007
First posted
Sep 11, 2003
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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