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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Given orally
Southwest Oncology Group
San Antonio, Texas, United States
Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting
Time frame: 1 year
Peak ZD1839 concentration level
Time frame: Up to 3 years
Elimination half-life
Time frame: Up to 3 years
Toxicity rates between the two age groups by CTCAE version 3.0
Time frame: Up to 3 years
Responses observed
Will be reported separately for the two tumor types, i.e., head and neck vs. lung cancer, with 95% confidence intervals for the estimated response rates.
Time frame: Up to 3 years
Survival for each tumor type
Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals.
Time frame: Up to 3 years
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