Iressa Versus Docetaxel (Taxotere)

NCT00076388 | Completed Phase 3

• 3 other identifiers: D791GC00001EudraCT No: 2004-002943-281839IL/0721
• Study Type: interventional
• Target: 1,440
• Locations: 24 countries
• Sites: 160

Brief Summary

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.

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To compare overall survival between ZD1839 and docetaxel

Secondary Outcomes (5)

• To compare time to progression (TTP) between ZD1839 and docetaxel

• To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel

• To compare the overall objective tumor response rate between ZD1839 and docetaxel

• To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel

• To compare safety and tolerability of ZD1839 and docetaxel

Interventions

Gefitinib DRUG

Docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
• Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
• Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
• WHO performance status (PS) 0-2
• Absolute Neutrophil Count (ANC) \>1.5 x 109/liter (L) and platelets \>100 x 109/L
• Life expectancy of at least 8 weeks

You may not qualify if:

• Prior ZD1839 therapy
• Prior docetaxel treatment for NSCLC
• Less than 14 days since completion of prior radiotherapy
• Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
• Evidence of clinically active Interstitial Lung Disease
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
• Patients with pre existing peripheral neuropathy \>= grade 2 (NCI CTC criteria)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (162)

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Birmingham, Alabama, United States

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Fountain Valley, California, United States

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Los Angeles, California, 90048, United States

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Santa Rosa, California, United States

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Stockton, California, 95204, United States

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Colorado Springs, Colorado, United States

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Norwich, Connecticut, United States

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Newark, Delaware, United States

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Boca Raton, Florida, United States

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Orlando, Florida, 32806, United States

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Macon, Georgia, United States

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Tucker, Georgia, United States

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Skokie, Illinois, 60077, United States

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Knoxville, Kentucky, United States

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Saint Louis Park, Minnesota, United States

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Great Neck, New York, 11021, United States

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Rochester, New York, 14621, United States

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Syracuse, New York, 13210, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, 27710, United States

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Cleveland, Ohio, 44195, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, 77030-4009, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, 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

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Buenos Aires, Argentina

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Córdoba, 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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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Santa Fe, Argentina

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Charleroi, Belgium

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Edegem, Belgium

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Genk, Belgium

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Godinne, Belgium

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Kortrijk, Belgium

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Leuven, Belgium

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Liège, Belgium

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Yvoir, Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Greater Sudbury, Ontario, Canada

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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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Saint Catherines, Ontario, Canada

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Toronto, Ontario, Canada

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York, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Ste-Foy, 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 Municipality, 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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Blois, France

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Boulogne-Billancourt, France

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Caen, France

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Grenoble, France

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Le Mans, France

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Lille, France

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Nantes, France

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Niort, France

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Saint-Herblain, France

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Vandœuvre-lès-Nancy, France

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Vesoul, France

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Heidelberg, Baden-Wurttemberg, Germany

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Ulm, Baden-Wurttemberg, Germany

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Cottbus, Brandenburg, Germany

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Frankfurt am Main, Hesse, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Bad Segeberg, Schleswig-Holstein, Germany

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Berlin, Germany

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Bonn, Germany

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Cologne, Germany

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Großhansdorf, Germany

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Leverkusen, Germany

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Löwenstein, Germany

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Mannheim, Germany

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München, Germany

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Stuttgart, Germany

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Wiesbaden, Germany

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Hong Kong, Hong Kong

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Jakarta, Indonesia

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Yogyakarta, Indonesia

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La Torretta, Ancona, Italy

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Bari, BA, Italy

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Bergamo, BG, Italy

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Bologna, BO, Italy

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Cuneo, CN, Italy

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Catania, CT, Italy

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Forlì, FO, Italy

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Melegnano, MI, Italy

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Rozzano, MI, Italy

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Modena, MO, Italy

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Parma, PR, Italy

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Roma, Roma, Italy

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Torino, TO, Italy

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Napoli, Italy

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Riga, Latvia

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Kampung Baharu Nilai, Malaysia

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Kuala Lumpur, Malaysia

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Guadalajara, Mexico

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Monterrey, Mexico

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Morelia, Mexico

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Torreón, Mexico

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Manila, Philippines

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Quezon City, Philippines

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Singapore, Singapore

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Ljubliana, Slovenia

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Elche, Alicante, Spain

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Barcelona, Barcelona, Spain

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Girona, Gerona, Spain

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Madrid, Madrid, Spain

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Málaga, Málaga, Spain

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Seville, Sevilla, Spain

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Valencia, Valencia, Spain

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Vitoria-Gasteiz, Spain

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Zaragoza, Spain

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Gothenburg, Sweden

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Luleå, Sweden

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Örebro, Sweden

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Östersund, Sweden

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Skövde, Sweden

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Stockholm, Sweden

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Sundsvall, Sweden

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Umeå, Sweden

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Västerås, Sweden

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Bellinzona, Switzerland

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Sankt Gallen, Switzerland

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Zurich, Switzerland

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Chiang Mai, Thailand

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Related Publications (3)

• Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.

  PMID: 33075149 DERIVED

• Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.

  PMID: 20038723 DERIVED

• Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.

  PMID: 19027483 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• AstraZeneca Iressa Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2004
• First Posted: January 23, 2004
• Study Start: February 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

BR (3); SE (9); IT (14); ES (9); US (35); MY (2); AR (8); CN (3); DE (17); ME (4); SG (1); SL (1); CH (3); HK (1); CA (14); PH (2); DK (6); FR (11); TH (1); BE (8); CR (2); ID (2); LA (1); TU (3)