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

PURPOSE: Phase I trial to study the effectiveness of gefitinib in treating patients who have metastatic or unresectable head and neck cancer or non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
Head and Neck Cancer thorax and respiratory cancer	Drug: gefitinib  Procedure: enzyme inhibitor therapy  Procedure: protein tyrosine kinase inhibitor therapy	Phase I

Further Study 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 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.

Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Manuel Valdivieso, MD,  Barbara Ann Karmanos Cancer Institute   
Shirish M. Gadgeel, MD,  Barbara Ann Karmanos Cancer Institute   

Study ID Numbers:  CDR0000322890; SWOG-S0322; NCT00068497
Record last reviewed:  April 2005
Last Updated:  April 5, 2005
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068497
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08