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

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068497

Purpose

RATIONALE: Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

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.

Condition	Intervention	Phase
Head and Neck Cancer Lung Cancer	Drug: gefitinib	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Single Agent ZD-1839 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:

MedlinePlus related topics: Cancer Head and Neck Cancer Lung Cancer Tonsils and Adenoids

Drug Information available for: ZD1839

U.S. FDA Resources

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

Study Start Date:	August 2003
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the feasibility of a structured pilot study that includes pharmacokinetic sampling in patients age 75 and over or age 50 and under with metastatic or unresectable head and neck cancer or non-small lung cancer treated with gefitinib.
Compare, preliminarily, the peak concentration level, elimination half-life, and steady state level of gefitinib between patients in these two 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.

PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer
- Metastatic or unresectable disease for which standard curative or palliative treatment measures do not exist or are no longer effective
Brain metastases allowed provided the metastases have been treated and are stable

PATIENT CHARACTERISTICS:

Age

50 and under or 75 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin normal
SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)

Renal

Creatinine normal

Cardiovascular

No severe unstable or uncompensated cardiac disease

Pulmonary

No severe unstable or uncompensated respiratory disease

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No other concurrent severe or uncontrolled systemic disease or infection
Able to swallow oral medication in pill form

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior epidermal growth factor receptor inhibitors
No concurrent immunotherapy for the malignancy

Chemotherapy

Prior chemotherapy allowed
No concurrent chemotherapy

Endocrine therapy

No concurrent hormonal therapy

Radiotherapy

No concurrent radiotherapy

Surgery

Not specified

Other

No concurrent agents that induce CYP3A4, including the following:
- Nafcillin
- Rifampin
- Carbamazepine
- Phenobarbital
- Phenytoin
- Oxcarbazepine
- Fosphenytoin
- Primidone
- Hypericum perforatum (St. John's wort)
- Rifabutin
- Rifapentine
- Modafinil
No concurrent retroviral therapies for HIV-positive patients
Recovered from prior therapy

Contacts and Locations

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

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Florida
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4095
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States, 79106
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Investigator:	Manuel Valdivieso, MD, MS, CPE	Barbara Ann Karmanos Cancer Institute
Investigator:	Shirish M. Gadgeel, MD	Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000322890, SWOG-S0322
Study First Received:	September 10, 2003
Last Updated:	February 14, 2009
ClinicalTrials.gov Identifier:	NCT00068497 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV salivary gland cancer
recurrent salivary gland cancer
recurrent non-small cell lung cancer
stage IV non-small cell lung 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
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
recurrent lymphoepithelioma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the oropharynx
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent basal cell carcinoma of the lip
stage IV basal cell carcinoma of the lip
recurrent verrucous carcinoma of the larynx
recurrent verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the larynx
stage IV verrucous carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity

Study placed in the following topic categories:

Thoracic Neoplasms
Laryngeal Carcinoma
Squamous Cell Carcinoma
Protein Kinase Inhibitors
Hypopharyngeal Cancer
Carcinoma, Adenoid Cystic
Respiratory Tract Diseases
Lung Neoplasms
Papilloma
Salivary Gland Diseases
Gefitinib
Nasopharyngeal Carcinoma
Carcinoma, Basal Cell

Granuloma
Recurrence
Carcinoma
Metastatic Squamous Neck Cancer With Occult Primary
Head and Neck Neoplasms
Lung Diseases
Epidermoid Carcinoma
Non-small Cell Lung Cancer
Adenoid Cystic Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Head and Neck Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Gefitinib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009