NCT00068497|Completed

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)

National Cancer Institute (NCI)ClinicalTrials.gov

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4 other identifiers

NCI-2012-03171S0322U10CA032102CDR0000322890

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredSep 2003

StartedAug 2003

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed

Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

September 10, 2003

Last Update Submit

January 11, 2013

Conditions

Outcome Measures

Primary Outcomes (6)

Feasibility of enrolling patients aged 75 or older and 50 or younger to the study setting
1 year
Peak ZD1839 concentration level
Up to 3 years
Elimination half-life
Up to 3 years
Toxicity rates between the two age groups by CTCAE version 3.0
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.
Up to 3 years
Survival for each tumor type
Kaplan-Meier curves will summarize with median estimates and associated 95% confidence intervals.
Up to 3 years

Study Arms (1)

Treatment (gefitinib)

EXPERIMENTAL

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.

Drug: gefitinib

Interventions

gefitinibDRUG

Given orally

Also known as: Iressa, ZD 1839

Treatment (gefitinib)

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
Patients must not be planning to receive concurrent radiation therapy, hormone therapy, chemotherapy or immune therapy for malignancy while receiving protocol treatment
Patients must agree to undergo pharmacokinetic sampling and sample submission
Patients known to be HIV positive and receiving retroviral therapies are not eligible
Patients with any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac or infection) are not eligible
Patients must be able to swallow oral medication in pill form; patients may not receive study medication through a feeding tube
+6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Thyroid Carcinoma, AnaplasticParathyroid NeoplasmsEsthesioneuroblastoma, OlfactoryCarcinoma, Non-Small-Cell LungSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and NeckThyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, PapillaryCarcinoma, MedullaryTongue Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesParathyroid DiseasesNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous CellThyroid DiseasesAdenocarcinomaAdenocarcinoma, PapillaryCarcinoma, NeuroendocrineNeuroendocrine TumorsNeoplasms, Ductal, Lobular, and MedullaryTongue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Shirish Gadgeel
SWOG Cancer Research Network
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

August 1, 2003

Primary Completion

December 1, 2007

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Study Arms (1)

Treatment (gefitinib)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations