Iressa Expanded Access Program (EAP)

Carcinoma Clinical Trial

Official title:

An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034879
• Other study ID #: 1839IL/0050
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2002
• Last updated: January 3, 2013
• Start date: August 2000
• Est. completion date: October 2003

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

For inclusion in this trial, patients must fulfill all of the following criteria:

• previous documented histologically or cytologically confirmed non-small cell lung cancer;

• locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy.

• age 18 years or older;

• written informed consent to participate in the trial.

Exclusion Criteria

Any of the following will exclude a patient from entering the trial:

• receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. * Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission;

• patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission;

• having other active malignancies;

• incomplete healing from previous oncologic or other major surgery;

• evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;

• pregnancy or breast feeding (women of child-bearing potential).

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Metastases
• Neoplasm
• Non-small-cell Lung

Intervention

Drug:
• ZD1839 (Gefitinib)

Locations

Country	Name	City	State
United States	Research Site	Aberdeen	South Dakota
United States	Research Site	Abilene	Texas
United States	Research Site	Abington	Virginia
United States	Research Site	Akron	Ohio
United States	Research Site	Alabaster	Alabama
United States	Research Site	Albany	Georgia
United States	Research Site	Albany	New York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Alexandria	Minnesota
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Amarillo	Texas
United States	Research Site	Ames	Iowa
United States	Research Site	Anaheim	California
United States	Research Site	Anchorage	Alaska
United States	Research Site	Anniston	Alabama
United States	Research Site	Appleton	Wisconsin
United States	Research Site	Arcadia	California
United States	Research Site	Arlington	Texas
United States	Research Site	Arlington Heights	Illinois
United States	Research Site	Asheville	North Carolina
United States	Research Site	Ashland	Kentucky
United States	Research Site	Athens	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Auburn	Washington
United States	Research Site	Aurora	Illinois
United States	Research Site	Austin	Texas
United States	Research Site	Bakersfield	California
United States	Research Site	Baldwin Park	California
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bangor	Maine
United States	Research Site	Barberton	Ohio
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Battle Kreek	Michigan
United States	Research Site	Bay City	Michigan
United States	Research Site	Bayshore	New York
United States	Research Site	Bayside	New York
United States	Research Site	Baytown	Texas
United States	Research Site	Beaumont	Texas
United States	Research Site	Belleville	New Jersey
United States	Research Site	Belleville	Illinois
United States	Research Site	Bellflower	California
United States	Research Site	Bemidji	Minnesota
United States	Research Site	Bend	Oregon
United States	Research Site	Bennington	Vermont
United States	Research Site	Bentonville	Arkansas
United States	Research Site	Berkeley	California
United States	Research Site	Berwyn	Illinois
United States	Research Site	Bethesda	Maryland
United States	Research Site	Bethlehem	Pennsylvania
United States	Research Site	Bettendorf	Iowa
United States	Research Site	Beverly	Massachusetts
United States	Research Site	Billings	Montana
United States	Research Site	Birmingham	Alabama
United States	Research Site	Bismarck	North Dakota
United States	Research Site	Bloomington	Indiana
United States	Research Site	Boca Raton	Florida
United States	Research Site	Boise	Idaho
United States	Research Site	Boone	North Carolina
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boulder	Colorado
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Bradenton	Florida
United States	Research Site	Brainerd	Minnesota
United States	Research Site	Branson	Missouri
United States	Research Site	Bremerton	Washington
United States	Research Site	Brockton	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Bronxville	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Brunswick	Georgia
United States	Research Site	Bryan	Ohio
United States	Research Site	Bryan	Texas
United States	Research Site	Bryn Mawr	Pennsylvania
United States	Research Site	Buffalo	New York
United States	Research Site	Burbank	California
United States	Research Site	Burlington	Massachusetts
United States	Research Site	Burlington	North Carolina
United States	Research Site	Butler	Pennsylvania
United States	Research Site	Camden	Arkansas
United States	Research Site	Campbell	California
United States	Research Site	Canton	Georgia
United States	Research Site	Canton	Ohio
United States	Research Site	Carrollton	Georgia
United States	Research Site	Cellarsville	Pennsylvania
United States	Research Site	Champaign	Illinois
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Cheyenne	Wyoming
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago Heights	Illinois
United States	Research Site	Chico	California
United States	Research Site	Chicopee	Massachusetts
United States	Research Site	Chino	California
United States	Research Site	Chule Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clarksburg	West Virginia
United States	Research Site	Clearwater	Florida
United States	Research Site	Cleveland	Ohio
United States	Research Site	Coeur d'Alene	Idaho
United States	Research Site	Collierville	Tennessee
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbia	Missouri
United States	Research Site	Columbus	Ohio
United States	Research Site	Concord	North Carolina
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United States	Research Site	Coos Bay	Oregon
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United States	Research Site	Eau Claire	Wisconsin
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United States	Research Site	Elizabeth	New Jersey
United States	Research Site	Elizabeth	North Carolina
United States	Research Site	Elk Grove Village	Illinois
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United States	Research Site	Flemington	New Jersey
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United States	Research Site	Fountain Valley	California
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United States	Research Site	Glens Falls	New York
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United States	Research Site	Grand Island	Nebraska
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Grass Valley	California
United States	Research Site	Great Falls	Montana
United States	Research Site	Great Neck	New York
United States	Research Site	Green Bay	Wisconsin
United States	Research Site	Greenbrae	California
United States	Research Site	Greensboro	North Carolina
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United States	Research Site	Greenville	North Carolina
United States	Research Site	Greenville	South Carolina
United States	Research Site	Greenwich	Connecticut
United States	Research Site	Grosse Point Woods	Michigan
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Hampton	Virginia
United States	Research Site	Handen	Connecticut
United States	Research Site	Harris	New York
United States	Research Site	Harrisburg	Pennsylvania
United States	Research Site	Hartford	Connecticut
United States	Research Site	Harvey	Illinois
United States	Research Site	Hattiesburg	Mississippi
United States	Research Site	Hays	Kansas
United States	Research Site	Hazard	Kentucky
United States	Research Site	Hazelton	Pennsylvania
United States	Research Site	Helena	Montana
United States	Research Site	Hickory	North Carolina
United States	Research Site	Hinsdale, IL	Illinois
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Hooksett	New Hampshire
United States	Research Site	Houston	Texas
United States	Research Site	Huntington	West Virginia
United States	Research Site	Huntington	New York
United States	Research Site	Huntington Station	New York
United States	Research Site	Huntsville	Alabama
United States	Research Site	Hutchinson	Kansas
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United States	Research Site	Irving	Texas
United States	Research Site	Ivins	Utah
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United States	Research Site	Jackson	Michigan
United States	Research Site	Jackson	Mississippi
United States	Research Site	Jacksonville	Florida
United States	Research Site	Janesville	Wisconsin
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United States	Research Site	Johnson City	New York
United States	Research Site	Joliet	Illinois
United States	Research Site	Joplin	Missouri
United States	Research Site	Jupiter	Florida
United States	Research Site	Kalamazoo	Michigan
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United States	Research Site	Kansas City	Kansas
United States	Research Site	Kennewick	Washington
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United States	Research Site	Key West	Florida
United States	Research Site	Kingston	Pennsylvania
United States	Research Site	Kinston	North Carolina
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United States	Research Site	La Jolla	California
United States	Research Site	Lafayette	Louisiana
United States	Research Site	Lake Charles	Louisiana
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United States	Research Site	Lansing	Michigan
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United States	Research Site	Los Gatos	California
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United States	Research Site	Lynchburg	Virginia
United States	Research Site	Macon	Georgia
United States	Research Site	Madison	Wisconsin
United States	Research Site	Mahwah	New Jersey
United States	Research Site	Malone	New York
United States	Research Site	Manasquan	New Jersey
United States	Research Site	Manchester	Connecticut
United States	Research Site	Manitowoc	Wisconsin
United States	Research Site	Mansfield	Ohio
United States	Research Site	Mansfield	Massachusetts
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United States	Research Site	Marquette	Michigan
United States	Research Site	Marshfield	Wisconsin
United States	Research Site	Mason City	Iowa
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United States	Research Site	Thiodaux	Louisiana
United States	Research Site	Thomasville	Georgia
United States	Research Site	Thousand Oaks	California
United States	Research Site	Toledo	Ohio
United States	Research Site	Topeka	Kansas
United States	Research Site	Torrington	Connecticut
United States	Research Site	Towson	Maryland
United States	Research Site	Traverse City	Michigan
United States	Research Site	Tripler AMC	Hawaii
United States	Research Site	Troy	Ohio
United States	Research Site	Trumbull	Connecticut
United States	Research Site	Tualatin	Oregon
United States	Research Site	Tucker	Georgia
United States	Research Site	Tucson	Arizona
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Twentynine Palm	California
United States	Research Site	Tyler	Texas
United States	Research Site	Union	New Jersey
United States	Research Site	Upland	California
United States	Research Site	Urbana	Illinois
United States	Research Site	Utica	New York
United States	Research Site	Valdese	North Carolina
United States	Research Site	Valdosta	Georgia
United States	Research Site	Valhalla	New York
United States	Research Site	Vallejo	California
United States	Research Site	Valley Stream	New York
United States	Research Site	Van Nuys	California
United States	Research Site	Vancouver	Washington
United States	Research Site	Vero Beach	Florida
United States	Research Site	Victoria	Texas
United States	Research Site	Voorhees	New Jersey
United States	Research Site	W Islip	New York
United States	Research Site	Waco	Texas
United States	Research Site	Wailuku	Hawaii
United States	Research Site	Waldorf	Maryland
United States	Research Site	Walla Walla	Texas
United States	Research Site	Walnut Creek	California
United States	Research Site	Walpole	Massachusetts
United States	Research Site	Wareham	Massachusetts
United States	Research Site	Warrensville Heights	Ohio
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Washington	District of Columbia
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Waterloo	Iowa
United States	Research Site	Waterville	Maine
United States	Research Site	Waukesha	Wisconsin
United States	Research Site	Wausau	Wisconsin
United States	Research Site	Way Cross	Georgia
United States	Research Site	Webster	Texas
United States	Research Site	Wellesley	Massachusetts
United States	Research Site	West Palm Beach	Florida
United States	Research Site	West Reading	Pennsylvania
United States	Research Site	Westerly	Rhode Island
United States	Research Site	Westlake Village	California
United States	Research Site	Westwood	New Jersey
United States	Research Site	Wheaton	Illinois
United States	Research Site	Wheeling	West Virginia
United States	Research Site	White Plains	New York
United States	Research Site	Wiliamsville	New York
United States	Research Site	Williamsburg	Virginia
United States	Research Site	Williamsville	New York
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Witchita	Kansas
United States	Research Site	Woburn	Massachusetts
United States	Research Site	Woodbury	New York
United States	Research Site	Woodland Hills	California
United States	Research Site	Woodridge	Virginia
United States	Research Site	Wooster	Ohio
United States	Research Site	Worchester	Massachusetts
United States	Research Site	York	Maine
United States	Research Site	York	Pennsylvania
United States	Research Site	Youngstown	Ohio
United States	Research Site	Ypsilanti	Michigan
United States	Research Site	Yuma	Arizona
United States	Research Site	Zanesville	Ohio
United States	Research Site	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States,