- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068497
Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
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)
Study Overview
Status
Conditions
- Insular Thyroid Cancer
- Recurrent Thyroid Cancer
- Stage IIIB Non-small Cell Lung Cancer
- Anaplastic Thyroid Cancer
- Tongue Cancer
- Recurrent Metastatic Squamous Neck Cancer With Occult Primary
- 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 Oropharynx
- Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Verrucous Carcinoma of the Larynx
- Recurrent Non-small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer
- Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
- Recurrent Basal Cell Carcinoma of the Lip
- Recurrent Lymphoepithelioma of the Nasopharynx
- Recurrent Lymphoepithelioma of the Oropharynx
- Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Squamous Cell Carcinoma of the Nasopharynx
- 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 IV Lymphoepithelioma of the Nasopharynx
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Nasopharynx
- Stage IVA Salivary Gland Cancer
- Stage IVA Squamous Cell Carcinoma of the Larynx
- 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 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 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
- Untreated Metastatic Squamous Neck Cancer With Occult Primary
- Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Follicular Thyroid Cancer
- Stage III Papillary Thyroid Cancer
- Thyroid Gland Medullary Carcinoma
- Stage IVA Follicular Thyroid Cancer
- Stage IVA Papillary Thyroid Cancer
- Stage IVB Follicular Thyroid Cancer
- Stage IVB Papillary Thyroid Cancer
- Stage IVC Follicular Thyroid Cancer
- Stage IVC Papillary Thyroid Cancer
- Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVA Basal Cell Carcinoma of the Lip
- Stage IVA Lymphoepithelioma of the Oropharynx
- Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVB Basal Cell Carcinoma of the Lip
- Stage IVB Lymphoepithelioma of the Oropharynx
- Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity
- Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
- Stage IVC Basal Cell Carcinoma of the Lip
- Stage IVC Lymphoepithelioma of the Oropharynx
- Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity
- Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Metastatic Parathyroid Cancer
- Recurrent Parathyroid Cancer
- Stage IVA Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IVA Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IVA Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage IVB Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IVB Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IVB Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
- Stage IVC Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
- Thryoid Gland Nonmedullary Carcinoma
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78245
- Southwest Oncology Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting
Time Frame: 1 year
|
1 year
|
|
Peak ZD1839 concentration level
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Elimination half-life
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Toxicity rates between the two age groups by CTCAE version 3.0
Time Frame: Up to 3 years
|
Up to 3 years
|
|
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.
|
Up to 3 years
|
Survival for each tumor type
Time Frame: Up to 3 years
|
Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirish Gadgeel, Southwest Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Lung Diseases
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Disease Attributes
- Endocrine Gland Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Parathyroid Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neoplastic Processes
- Paranasal Sinus Diseases
- Nose Diseases
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Neoplasm Metastasis
- Neuroectodermal Tumors, Primitive
- Neoplasms, Squamous Cell
- Neoplasms, Cystic, Mucinous, and Serous
- Nasopharyngeal Neoplasms
- Neoplasms, Basal Cell
- Neuroectodermal Tumors, Primitive, Peripheral
- Salivary Gland Diseases
- Adenocarcinoma, Papillary
- Carcinoma, Neuroendocrine
- Mouth Neoplasms
- Neoplasms, Ductal, Lobular, and Medullary
- Olfactory Nerve Diseases
- Tongue Diseases
- Nose Neoplasms
- Neuroblastoma
- Head and Neck Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Nasopharyngeal Carcinoma
- Recurrence
- Thyroid Diseases
- Carcinoma, Adenoid Cystic
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Granuloma
- Thyroid Neoplasms
- Thyroid Cancer, Papillary
- Adenocarcinoma, Follicular
- Neoplasms, Unknown Primary
- Oropharyngeal Neoplasms
- Salivary Gland Neoplasms
- Esthesioneuroblastoma, Olfactory
- Carcinoma, Basal Cell
- Papilloma
- Laryngeal Neoplasms
- Parathyroid Neoplasms
- Laryngeal Diseases
- Carcinoma, Medullary
- Carcinoma, Verrucous
- Thyroid Carcinoma, Anaplastic
- Tongue Neoplasms
- Carcinoma, Mucoepidermoid
- Mucoepidermoid Tumor
- Paranasal Sinus Neoplasms
- Papilloma, Inverted
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Gefitinib
Other Study ID Numbers
- NCI-2012-03171
- U10CA032102 (U.S. NIH Grant/Contract)
- S0322
- CDR0000322890 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insular Thyroid Cancer
-
Bhavana KondaNational Comprehensive Cancer NetworkActive, not recruitingInsular Thyroid Cancer | Recurrent Thyroid Cancer | Papillary Thyroid Cancer | Follicular Thyroid CancerUnited States
-
National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Thyroid Gland Medullary CarcinomaUnited States
-
University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
-
Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
-
Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
Clinical Trials on gefitinib
-
Sun Yat-sen UniversityUnknown
-
Qilu Pharmaceutical Co., Ltd.UnknownNon-small-cell Lung CancerChina
-
Sun Yat-sen UniversityWu Jieping Medical FoundationCompletedNon-small Cell Lung CancerChina
-
Jiangsu Famous Medical Technology Co., Ltd.UnknownNon-small Cell Lung Cancer
-
AstraZenecaCompletedNeoplasms, Squamous CellUnited States, Czech Republic, Poland, Germany, Belgium, Taiwan, India, Serbia
-
Anhui Medical UniversityUnknownSelf Efficacy | Drug ToxicityChina
-
NCIC Clinical Trials GroupCompletedProstate CancerCanada
-
University of Maryland, BaltimoreNational Cancer Institute (NCI); University of Maryland Greenebaum Cancer CenterCompleted
-
Samsung Medical CenterUnknownNon-small Cell Lung CancerKorea, Republic of
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada, United Kingdom, Australia