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| 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) |
| Study Start Date: | August 2003 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent agents that induce CYP3A4, including the following:
Contacts and 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 | |
| Investigator: | Manuel Valdivieso, MD, MS, CPE | Barbara Ann Karmanos Cancer Institute |
| Investigator: | Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| 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 |
|
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 |
|
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 |
|
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 |