Clinical Trials Directory

Trials / Completed

CompletedNCT00068497

Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGgefitinibGiven orally

Timeline

Start date
2003-08-01
Primary completion
2007-12-01
First posted
2003-09-11
Last updated
2013-01-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00068497. Inclusion in this directory is not an endorsement.