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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Young

Brief 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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • 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 [ Time Frame: Up to 3 years ]
    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.
  • Survival for each tumor type [ Time Frame: Up to 3 years ]
    Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 10, 2003
Date Started: August 2003
Date Completion:
Last Updated: January 11, 2013
Last Verified: January 2013