Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
Single Agent ZD-1839 (NSC-715055, IND-61187) 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)
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. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
PRIMARY OBJECTIVES:
I. To assess the feasibility of enrolling patients ages 75 years or older and 50 years and
younger with metastatic or unresectable head and neck cancer or non-small cell lung cancer,
to a structured pilot study that includes pharmacokinetic sampling in a special patient
population.
II. To preliminarily compare the ZD-1839 peak concentration level, elimination half-life and
steady state level between the two patient 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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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