Iressa Versus Docetaxel (Taxotere)

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small-Cell Lung Carcinoma
• Intervention / Treatment: Drug: Docetaxel; Drug: Gefitinib

• Study Type: Interventional
• Enrollment: 1440
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Research Site
  • Cordoba, Argentina
    • Research Site
  • El Palomar, Argentina
    • Research Site
  • Mar del Plata, Argentina
    • Research Site
  • Quilmes, Argentina
    • Research Site
  • Rosario, Argentina
    • Research Site
  • San Miguel de Tucuman, Argentina
    • Research Site
  • Santa Fe, Argentina
    • Research Site
• Belgium
  • Charleroi, Belgium
    • Research Site
  • Edegem, Belgium
    • Research Site
  • Genk, Belgium
    • Research Site
  • Godinne, Belgium
    • Research Site
  • Kortrijk, Belgium
    • Research Site
  • Leuven, Belgium
    • Research Site
  • Liège, Belgium
    • Research Site
  • Yvoir, Belgium
    • Research Site
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil
      • Research Site
  • RS
    • Porto Alegre, RS, Brazil
      • Research Site
  • SP
    • Sao Paulo, SP, Brazil
      • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Research Site
  • British Columbia
    • Surrey, British Columbia, Canada
      • Research Site
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada
      • Research Site
    • London, Ontario, Canada
      • Research Site
    • Newmarket, Ontario, Canada
      • Research Site
    • St. Catherines, Ontario, Canada
      • Research Site
    • Sudbury, Ontario, Canada
      • Research Site
    • Toronto, Ontario, Canada
      • Research Site
    • York, Ontario, Canada
      • Research Site
  • Quebec
    • Laval, Quebec, Canada
      • Research Site
    • Montreal, Quebec, Canada
      • Research Site
    • Ste-Foy, Quebec, Canada
      • Research Site
• China
  • Beijing, China
    • Research Site
  • Guangzhou, China
    • Research Site
  • Shanghai, China
    • Research Site
• Croatia
  • Split, Croatia
    • Research Site
  • Zagreb, Croatia
    • Research Site
• Denmark
  • Aalborg, Denmark
    • Research Site
  • Arhus C, Denmark
    • Research Site
  • Glostrup, Denmark
    • Research Site
  • Herlev, Denmark
    • Research Site
  • København Ø, Denmark
    • Research Site
  • Vejle, Denmark
    • Research Site
• Estonia
  • Tallinn, Estonia
    • Research Site
  • Tartu, Estonia
    • Research Site
• France
  • Blois, France
    • Research Site
  • Boulogne Billancourt, France
    • Research Site
  • Caen Cedex, France
    • Research Site
  • Grenoble Cedex 09, France
    • Research Site
  • Le Mans, France
    • Research Site
  • Lille Cedex, France
    • Research Site
  • Nantes, France
    • Research Site
  • Niort, France
    • Research Site
  • Saint Herblain, France
    • Research Site
  • Vandoeuvre Les Nancy, France
    • Research Site
  • Vesoul Cedex, France
    • Research Site
• Germany
  • Berlin, Germany
    • Research Site
  • Bonn, Germany
    • Research Site
  • Großhansdorf, Germany
    • Research Site
  • Köln, Germany
    • Research Site
  • Leverkusen, Germany
    • Research Site
  • Löwenstein, Germany
    • Research Site
  • Mannheim, Germany
    • Research Site
  • München, Germany
    • Research Site
  • Stuttgart, Germany
    • Research Site
  • Wiesbaden, Germany
    • Research Site
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany
      • Research Site
    • Ulm, Baden-Württemberg, Germany
      • Research Site
  • Brandenburg
    • Cottbus, Brandenburg, Germany
      • Research Site
  • Hessen
    • Frankfurt, Hessen, Germany
      • Research Site
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany
      • Research Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany
      • Research Site
  • Schleswig-Holstein
    • Bad Segeberg, Schleswig-Holstein, Germany
      • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research Site
• Indonesia
  • Jakarta, Indonesia
    • Research Site
  • Yogyakarta, Indonesia
    • Research Site
• Italy
  • Napoli, Italy
    • Research Site
  • Roma, Italy
    • Research Site
  • Ancona
    • La Torretta, Ancona, Italy
      • Research Site
  • BA
    • Bari, BA, Italy
      • Research Site
  • BG
    • Bergamo, BG, Italy
      • Research Site
  • BO
    • Bologna, BO, Italy
      • Research Site
  • CN
    • Cuneo, CN, Italy
      • Research Site
  • CT
    • Catania, CT, Italy
      • Research Site
  • FO
    • Forli', FO, Italy
      • Research Site
  • MI
    • Melegnano, MI, Italy
      • Research Site
    • Rozzano, MI, Italy
      • Research Site
  • MO
    • Modena, MO, Italy
      • Research Site
  • PR
    • Parma, PR, Italy
      • Research Site
  • TO
    • Torino, TO, Italy
      • Research Site
• Latvia
  • Riga, Latvia
    • Research Site
• Malaysia
  • Kuala Lumpur, Malaysia
    • Research Site
  • Nilai, Malaysia
    • Research Site
• Mexico
  • Guadalajara, Mexico
    • Research Site
  • Monterrey, Mexico
    • Research Site
  • Morelia, Mexico
    • Research Site
  • Torreon, Mexico
    • Research Site
• Philippines
  • Manila, Philippines
    • Research Site
  • Quezon City, Philippines
    • Research Site
• Singapore
  • Singapore, Singapore
    • Research Site
• Slovenia
  • Ljubliana, Slovenia
    • Research Site
• Spain
  • Barcelona, Spain
    • Research Site
  • Gerona, Spain
    • Research Site
  • Madrid, Spain
    • Research Site
  • Málaga, Spain
    • Research Site
  • Sevilla, Spain
    • Research Site
  • Valencia, Spain
    • Research Site
  • Vitoria, Spain
    • Research Site
  • Zaragoza, Spain
    • Research Site
  • Alicante
    • Elche, Alicante, Spain
      • Research Site
• Sweden
  • Goteborg, Sweden
    • Research Site
  • Luleå, Sweden
    • Research Site
  • Skövde, Sweden
    • Research Site
  • Stockholm, Sweden
    • Research Site
  • Sundsvall, Sweden
    • Research Site
  • Umeå, Sweden
    • Research Site
  • Vasteras, Sweden
    • Research Site
  • Örebro, Sweden
    • Research Site
  • Östersund, Sweden
    • Research Site
• Switzerland
  • Bellinzona, Switzerland
    • Research Site
  • St. Gallen, Switzerland
    • Research Site
  • Zürich, Switzerland
    • Research Site
• Thailand
  • Chiang Mai, Thailand
    • Research Site
• Turkey
  • Ankara, Turkey
    • Research Site
  • Istanbul, Turkey
    • Research Site
  • Izmir, Turkey
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Research Site
  • California
    • Fountain Valley, California, United States
      • Research Site
    • Los Angeles, California, United States, 90048
      • Research Site
    • Santa Rosa, California, United States
      • Research Site
    • Stockton, California, United States, 95204
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States
      • Research Site
  • Connecticut
    • Norwich, Connecticut, United States
      • Research Site
  • Delaware
    • Newark, Delaware, United States
      • Research Site
  • Florida
    • Boca Raton, Florida, United States
      • Research Site
    • Orlando, Florida, United States, 32806
      • Research Site
  • Georgia
    • Macon, Georgia, United States
      • Research Site
    • Tucker, Georgia, United States
      • Research Site
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Research Site
  • Kentucky
    • Knoxville, Kentucky, United States
      • Research Site
  • Minnesota
    • St. Louis Park, Minnesota, United States
      • Research Site
  • New York
    • Great Neck, New York, United States, 11021
      • Research Site
    • Rochester, New York, United States, 14621
      • Research Site
    • Syracuse, New York, United States, 13210
      • Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Research Site
    • Charlotte, North Carolina, United States
      • Research Site
    • Durham, North Carolina, United States, 27710
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Research Site
  • Oregon
    • Portland, Oregon, United States
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Research Site
    • Pittsburgh, Pennsylvania, United States
      • Research Site
  • South Carolina
    • Columbia, South Carolina, United States
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States
      • Research Site
  • Texas
    • Austin, Texas, United States
      • Research Site
    • Dallas, Texas, United States
      • Research Site
    • Houston, Texas, United States, 77030-4009
      • Research Site
    • Tyler, Texas, United States
      • Research Site
  • Utah
    • Salt Lake City, Utah, United States
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States
      • Research Site
  • Washington
    • Seattle, Washington, United States
      • Research Site
  • Wisconsin
    • Racine, Wisconsin, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare overall survival between ZD1839 and docetaxel

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: AstraZeneca Iressa Medical Science Director, MD, AstraZeneca

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: January 21, 2004
• First Submitted That Met QC Criteria: January 22, 2004
• First Posted (Estimate): January 23, 2004

Study Record Updates

• Last Update Posted (Estimate): May 13, 2011
• Last Update Submitted That Met QC Criteria: May 12, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Non-Small-Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Gefitinib
• Other Study ID Numbers: D791GC00001; EudraCT No: 2004-002943-28; 1839IL/0721