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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00076388 |
Purpose
The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Carcinoma |
Drug: Gefitinib Drug: Docetaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy |
| Estimated Enrollment: | 1440 |
| Study Start Date: | February 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
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| Birmingham, Alabama, United States | |
| United States, California | |
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| Los Angeles, California, United States, 90048 | |
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| Stockton, California, United States, 95204 | |
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| Santa Rosa, California, United States | |
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| Fountain Valley, California, United States | |
| United States, Colorado | |
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| Colorado Springs, Colorado, United States | |
| United States, Connecticut | |
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| Norwich, Connecticut, United States | |
| United States, Delaware | |
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| Newark, Delaware, United States | |
| United States, Florida | |
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| Orlando, Florida, United States, 32806 | |
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| Boca Raton, Florida, United States | |
| United States, Georgia | |
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| Macon, Georgia, United States | |
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| Tucker, Georgia, United States | |
| United States, Illinois | |
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| Skokie, Illinois, United States, 60077 | |
| United States, Kentucky | |
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| Knoxville, Kentucky, United States | |
| United States, Minnesota | |
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| St. Louis Park, Minnesota, United States | |
| United States, New York | |
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| Syracuse, New York, United States, 13210 | |
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| Great Neck, New York, United States, 11021 | |
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| Rochester, New York, United States, 14621 | |
| United States, North Carolina | |
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| Durham, North Carolina, United States, 27710 | |
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| Chapel Hill, North Carolina, United States, 27599 | |
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| Charlotte, North Carolina, United States | |
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| Cleveland, Ohio, United States, 44195 | |
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| Portland, Oregon, United States | |
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| Pittsburgh, Pennsylvania, United States | |
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| Philadelphia, Pennsylvania, United States | |
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| Columbia, South Carolina, United States | |
| United States, Tennessee | |
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| Nashville, Tennessee, United States | |
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| Houston, Texas, United States, 77030-4009 | |
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| Austin, Texas, United States | |
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| Dallas, Texas, United States | |
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| Tyler, Texas, United States | |
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| Fairfax, Virginia, United States | |
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| Seattle, Washington, United States | |
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| Racine, Wisconsin, United States | |
| Argentina | |
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| Rosario, Argentina | |
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| El Palomar, Argentina | |
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| Mar del Plata, Argentina | |
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| Quilmes, Argentina | |
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| Cordoba, Argentina | |
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| Santa Fe, Argentina | |
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| San Miguel de Tucuman, Argentina | |
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| Buenos Aires, Argentina | |
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| Charleroi, Belgium | |
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| Edegem, Belgium | |
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| Yvoir, Belgium | |
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| Kortrijk, Belgium | |
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| Leuven, Belgium | |
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| Liège, Belgium | |
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| Godinne, Belgium | |
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| Rio de Janeiro, RJ, Brazil | |
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| Porto Alegre, RS, Brazil | |
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| Sao Paulo, SP, Brazil | |
| Canada, Alberta | |
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| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
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| Surrey, British Columbia, Canada | |
| Canada, New Brunswick | |
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| Moncton, New Brunswick, Canada | |
| Canada, Nova Scotia | |
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| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
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| Hamilton, Ontario, Canada | |
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| London, Ontario, Canada | |
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| Newmarket, Ontario, Canada | |
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| St. Catherines, Ontario, Canada | |
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| Sudbury, Ontario, Canada | |
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| York, Ontario, Canada | |
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| Montreal, Quebec, Canada | |
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| Ste-Foy, Quebec, Canada | |
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| Laval, Quebec, Canada | |
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| Beijing, China | |
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| Guangzhou, China | |
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| Shanghai, China | |
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| Split, Croatia | |
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| Zagreb, Croatia | |
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| Aalborg, Denmark | |
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| Arhus C, Denmark | |
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| Glostrup, Denmark | |
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| Herlev, Denmark | |
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| København Ø, Denmark | |
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| Vejle, Denmark | |
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| Tallinn, Estonia | |
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| Tartu, Estonia | |
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| NANTES, France | |
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| BLOIS, France | |
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| BOULOGNE BILLANCOURT, France | |
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| CAEN CEDEX, France | |
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| GRENOBLE CEDEX 09, France | |
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| LE MANS, France | |
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| VESOUL CEDEX, France | |
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| NIORT, France | |
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| SAINT HERBLAIN, France | |
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| VANDOEUVRE LES NANCY, France | |
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| LILLE CEDEX, France | |
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| Wiesbaden, Germany | |
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| Bonn, Germany | |
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| Großhansdorf, Germany | |
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| Mannheim, Germany | |
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| Köln, Germany | |
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| Leverkusen, Germany | |
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| Löwenstein, Germany | |
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| München, Germany | |
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| Berlin, Germany | |
| Germany, Baden-Württemberg | |
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| Heidelberg, Baden-Württemberg, Germany | |
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| Ulm, Baden-Württemberg, Germany | |
| Germany, Brandenburg | |
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| Cottbus, Brandenburg, Germany | |
| Germany, Hessen | |
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| Frankfurt, Hessen, Germany | |
| Germany, Nordrhein-Westfalen | |
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| Düsseldorf, Nordrhein-Westfalen, Germany | |
| Germany, Rheinland-Pfalz | |
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| Mainz, Rheinland-Pfalz, Germany | |
| Germany, Schleswig-Holstein | |
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| Bad Segeberg, Schleswig-Holstein, Germany | |
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| Yogyakarta, Indonesia | |
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| Roma, Italy | |
| Italy, Ancona | |
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| La Torretta, Ancona, Italy | |
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| Riga, Latvia | |
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| Kuala Lumpur, Malaysia | |
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| Nilai, Malaysia | |
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| Torreon, Mexico | |
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| Guadalajara, Mexico | |
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| Morelia, Mexico | |
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| Monterrey, Mexico | |
| Philippines | |
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| Manila, Philippines | |
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| Quezon City, Philippines | |
| Singapore | |
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| Singapore, Singapore | |
| Slovenia | |
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| Ljubliana, Slovenia | |
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| Madrid, Spain | |
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| Vitoria, Spain | |
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| Barcelona, Spain | |
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| Gerona, Spain | |
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| Zaragoza, Spain | |
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| Málaga, Spain | |
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| Sevilla, Spain | |
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| Valencia, Spain | |
| Spain, Alicante | |
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| Elche, Alicante, Spain | |
| Sweden | |
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| LULEÅ, Sweden | |
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| Umeå, Sweden | |
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| ÖSTERSUND, Sweden | |
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| SKÖVDE, Sweden | |
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| Sundsvall, Sweden | |
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| Örebro, Sweden | |
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| Vasteras, Sweden | |
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| Goteborg, Sweden | |
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| Stockholm, Sweden | |
| Switzerland | |
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| Bellinzona, Switzerland | |
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| St. Gallen, Switzerland | |
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| Zürich, Switzerland | |
| Thailand | |
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| Chiang Mai, Thailand | |
| Turkey | |
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| Istanbul, Turkey | |
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| Ankara, Turkey | |
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| Izmir, Turkey | |
| Study Director: | AstraZeneca Iressa Medical Science Director, MD | AstraZeneca |
More Information
| Study ID Numbers: | 1839IL/0721, EudraCT No: 2004-002943-28, D791GC00001 |
| Study First Received: | January 21, 2004 |
| Last Updated: | January 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00076388 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Non-Small-Cell Lung Cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Docetaxel |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |