Clinical trial NCT00076388: Iressa Versus Docetaxel (Taxotere)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Non-Small-Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-01-23
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: To compare overall survival between ZD1839 and docetaxel
Secondary outcomes:
measure: To compare time to progression (TTP) between ZD1839 and docetaxel
measure: To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
measure: To compare the overall objective tumor response rate between ZD1839 and docetaxel
measure: To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
measure: To compare safety and tolerability of ZD1839 and docetaxel
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Norwich
country: United States
facility: Research Site
state: Connecticut
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Tucker
country: United States
facility: Research Site
state: Georgia
city: Skokie
country: United States
facility: Research Site
state: Illinois
city: Knoxville
country: United States
facility: Research Site
state: Kentucky
city: St. Louis Park
country: United States
facility: Research Site
state: Minnesota
city: Great Neck
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Racine
country: United States
facility: Research Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: El Palomar
country: Argentina
facility: Research site
city: Mar del Plata
country: Argentina
facility: Research Site
city: Quilmes
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Godinne
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: St. Catherines
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: York
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Research Site
state: Quebec
city: Beijing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Split
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Arhus C
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: København Ø
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Blois
country: France
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Caen Cedex
country: France
facility: Research Site
city: Grenoble Cedex 09
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Niort
country: France
facility: Research Site
city: Saint Herblain
country: France
facility: Research Site
city: Vandoeuvre Les Nancy
country: France
facility: Research Site
city: Vesoul Cedex
country: France
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Research Site
state: Baden-Württemberg
city: Cottbus
country: Germany
facility: Research Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: Research Site
state: Hessen
city: Düsseldorf
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Research Site
state: Rheinland-Pfalz
city: Bad Segeberg
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Löwenstein
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Jakarta
country: Indonesia
facility: Research Site
city: Yogyakarta
country: Indonesia
facility: Research Site
city: La Torretta
country: Italy
facility: Research Site
state: Ancona
city: Bari
country: Italy
facility: Research Site
state: BA
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Cuneo
country: Italy
facility: Research Site
state: CN
city: Catania
country: Italy
facility: Research Site
state: CT
city: Forli'
country: Italy
facility: Research Site
state: FO
city: Melegnano
country: Italy
facility: Research Site
state: MI
city: Rozzano
country: Italy
facility: Research Site
state: MI
city: Modena
country: Italy
facility: Research Site
state: MO
city: Parma
country: Italy
facility: Research Site
state: PR
city: Torino
country: Italy
facility: Research Site
state: TO
city: Napoli
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Nilai
country: Malaysia
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Morelia
country: Mexico
facility: Research Site
city: Torreon
country: Mexico
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Ljubliana
country: Slovenia
facility: Research Site
city: Elche
country: Spain
facility: Research Site
state: Alicante
city: Barcelona
country: Spain
facility: Research Site
city: Gerona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Vitoria
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Luleå
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Östersund
country: Sweden
facility: Research Site
city: Bellinzona
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Iressa Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.