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Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer  Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
For Condition: Head and Neck Cancer,thorax and respiratory cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of gefitinib in treating patients who have metastatic or unresectablehead and neck cancer or non-small cell lung cancer.
Details: 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 every 6 months 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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 - Previously treated with at least 1 and no more than 3 prior chemotherapeutic regimens, including prior adjuvant chemotherapy if completed within the past year - No known brain metastases PATIENT CHARACTERISTICS: Age - 50 and under or 75 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - SGOT or SGPT no greater than ULN - Alkaline phosphatase no greater than ULN Renal - Creatinine no greater than ULN 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 - See Disease Characteristics - 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 - St. John's wort - Rifabutin - Rifapentine - Modafinil - No concurrent retroviral therapies for HIV-positive patients - Recovered from prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KimMargolin, , Beckman Research Institute
University of Texas - MD Anderson Cancer Center*Recruiting*
Houston, Texas, 77030-4095
United States
RecruitingScott Lippman 713-745-3672
Barbara Ann Karmanos Cancer Institute*Recruiting*
Detroit, Michigan, 48201-1379
United States
RecruitingLawrence Flaherty 313-745-9155
City of Hope Comprehensive Cancer Center*Recruiting*
Duarte, California, 91010-0269
United States
RecruitingKim Margolin 626-359-8111
Veterans Affairs Medical Center - Biloxi*Recruiting*
Biloxi, Mississippi, 39531-2410
United States
RecruitingRobert Veith 504-568-5151
University of Texas Health Science Center at San Antonio*Recruiting*
San Antonio, Texas, 78229-3900
United States
RecruitingGeoffrey Weiss 210-617-5120
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus*Recruiting*
Seattle, Washington, 98104
United States
RecruitingSaul Rivkin 206-386-2441
Cleveland Clinic Taussig Cancer Center*Recruiting*
Cleveland, Ohio, 44195-9001
United States
RecruitingGeorge Budd 216-444-6480
University of Colorado Cancer Center at University of Colorado Health Sciences Center*Recruiting*
Aurora, Colorado, 80010
United States
RecruitingAnthony Elias 720-848-1622
Kansas Cancer Institute at the University of Kansas Medical Center*Recruiting*
Kansas City, Kansas, 66160-7353
United States
RecruitingSarah Taylor 913-588-6029
University of California Davis Cancer Center*Recruiting*
Sacramento, California, 95817
United States
RecruitingAngela Davies 916-734-3771
USC/Norris Comprehensive Cancer Center and Hospital*Recruiting*
Los Angeles, California, 90033
United States
RecruitingHeinz-Josef Lenz 323-865-3955
Cardinal Bernardin Cancer Center at Loyola University Medical Center*Recruiting*
Maywood, Illinois, 60153-5500
United States
RecruitingPatrick Stiff 708-327-3148
Additional Information:
Study ID Numbers: CDR0000322890; SWOG-S0322
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068497
Other Head And Neck CancerStudies:
1. Biological Therapy in Treating Patients With Metastatic Cancer
2. Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia
3. Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
4. Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function
5. A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors
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Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
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