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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 |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Lung Cancer |
| Drug Information available for: | ZD1839 Salicylsalicylic acid Sodium salicylate |
| 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 |
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 | |||||
| Southwest Oncology Group |
| National Cancer Institute (NCI) |
| Investigator: | Manuel Valdivieso, MD, MS, CPE | Barbara Ann Karmanos Cancer Institute |
| Investigator: | Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000322890, SWOG-S0322 |
| First Received: | September 10, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068497 |
| Health Authority: | United States: Federal Government |
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