NCT00068497

Completed

Not Applicable

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)

National Cancer Institute (NCI)1 site in 1 country40 target enrollmentAugust 2003

Interventionsgefitinib

Drugsgefitinib

Overview

Phase: Not Applicable
Intervention: gefitinib
Conditions: Anaplastic Thyroid Cancer
Sponsor: National Cancer Institute (NCI)
Enrollment: 40
Locations: 1
Primary Endpoint: Peak ZD1839 concentration level
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

August 2003

End Date

December 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Institute (NCI)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have histologically or cytologically confirmed head and neck carcinoma or non-small cell lung cancer which is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective or are likely to be as effective as ZD1839; patients with known brain metastases are only eligible if their brain metastases have been treated and if in the opinion of the treating physician they are stable
•Patients must be 75 years or older, or 50 years of age or younger
•Serum creatinine =\< the institutional upper limit of normal
•Bilirubin =\< the institutional upper limit of normal
•SGOT or SGPT =\< 2.5 x the institutional upper limit of normal; SGOT and SGPT could be =\< 5 x the upper limit of normal if the patient has liver metastases as long as the bilirubin is normal
•AGC of \>= 1,500/ul
•Platelet count of \>= 100,000/ul
•Patients requiring agents that induce CYP3A4 are excluded from the study, at the present time, agents known to induce CYP3A4 include the antibiotics nafcillin and rifampin, the anticonvulsants carbamazepine, phenobarbital, phenytoin, oxcarbazepine, fosphenytoin and primidone as well as St. John's Wort, rifabutin, rifapentine and modafinil
•Patients may or may not have received prior chemotherapy; patients must not have a curative option and in the opinion of the treating physician there is no other treatment option likely to provide greater benefit; patients must not have received prior treatment with EGFR inhibitors; patients must have recovered from the effects of prior therapy; all prior therapies must be documented
•Patients must have a performance status of 0-2 by Zubrod standards

Exclusion Criteria

Not provided

Arms & Interventions

Treatment (gefitinib)

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.

Intervention: gefitinib

Outcomes

Primary Outcomes

Peak ZD1839 concentration level

Time Frame: Up to 3 years

Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting

Time Frame: 1 year

Toxicity rates between the two age groups by CTCAE version 3.0

Time Frame: Up to 3 years

Survival for each tumor type

Time Frame: Up to 3 years

Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals.

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.

Elimination half-life

Time Frame: Up to 3 years