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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068497
First received: September 10, 2003
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Anaplastic Thyroid Cancer
Insular Thyroid Cancer
Metastatic Parathyroid Cancer
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
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 Gland Medullary Carcinoma
Tongue Cancer
Untreated Metastatic Squamous Neck Cancer With Occult Primary
Drug: gefitinib

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Peak ZD1839 concentration level [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Elimination half-life [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Toxicity rates between the two age groups by CTCAE version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Responses observed [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.

  • Survival for each tumor type [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals.


Estimated Enrollment: 40
Study Start Date: August 2003
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (gefitinib)
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.
Drug: gefitinib
Given orally
Other Names:
  • Iressa
  • ZD 1839

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068497

Locations
United States, Texas
Southwest Oncology Group
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: Shirish Gadgeel Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068497     History of Changes
Other Study ID Numbers: NCI-2012-03171, S0322, U10CA032102, CDR0000322890
Study First Received: September 10, 2003
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma, Follicular
Carcinoma
Carcinoma, Adenoid Cystic
Carcinoma, Basal Cell
Carcinoma, Medullary
Carcinoma, Mucoepidermoid
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Esthesioneuroblastoma, Olfactory
Granuloma
Head and Neck Neoplasms
Laryngeal Diseases
Laryngeal Neoplasms
Lung Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Unknown Primary
Oropharyngeal Neoplasms
Papilloma
Papilloma, Inverted
Paranasal Sinus Neoplasms
Salivary Gland Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Adenocarcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Carcinoma, Neuroendocrine
Cranial Nerve Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014