Iressa Versus Docetaxel (Taxotere)

Non-Small-Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076388
• Other study ID #: D791GC00001
• Secondary ID: EudraCT No: 2004
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2004
• Last updated: May 12, 2011
• Start date: February 2004
• Est. completion date: October 2007

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: October 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• Gefitinib

• Docetaxel

Locations

Country	Name	City	State
Argentina	Research Site	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
Belgium	Research Site	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
Brazil	Research Site	Porto Alegre	RS
Brazil	Research Site	Rio de Janeiro	RJ
Brazil	Research Site	Sao Paulo	SP
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	St. Catherines	Ontario
Canada	Research Site	Ste-Foy	Quebec
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	York	Ontario
China	Research Site	Beijing
China	Research Site	Guangzhou
China	Research Site	Shanghai
Croatia	Research Site	Split
Croatia	Research Site	Zagreb
Denmark	Research Site	Aalborg
Denmark	Research Site	Arhus C
Denmark	Research Site	Glostrup
Denmark	Research Site	Herlev
Denmark	Research Site	København Ø
Denmark	Research Site	Vejle
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
France	Research Site	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
Germany	Research Site	Bad Segeberg	Schleswig-Holstein
Germany	Research Site	Berlin
Germany	Research Site	Bonn
Germany	Research Site	Cottbus	Brandenburg
Germany	Research Site	Düsseldorf	Nordrhein-Westfalen
Germany	Research Site	Frankfurt	Hessen
Germany	Research Site	Großhansdorf
Germany	Research Site	Heidelberg	Baden-Württemberg
Germany	Research Site	Köln
Germany	Research Site	Leverkusen
Germany	Research Site	Löwenstein
Germany	Research Site	Mainz	Rheinland-Pfalz
Germany	Research Site	Mannheim
Germany	Research Site	München
Germany	Research Site	Stuttgart
Germany	Research Site	Ulm	Baden-Württemberg
Germany	Research Site	Wiesbaden
Hong Kong	Research Site	Hong Kong
Indonesia	Research Site	Jakarta
Indonesia	Research Site	Yogyakarta
Italy	Research Site	Bari	BA
Italy	Research Site	Bergamo	BG
Italy	Research Site	Bologna	BO
Italy	Research Site	Catania	CT
Italy	Research Site	Cuneo	CN
Italy	Research Site	Forli'	FO
Italy	Research Site	La Torretta	Ancona
Italy	Research Site	Melegnano	MI
Italy	Research Site	Modena	MO
Italy	Research Site	Napoli
Italy	Research Site	Parma	PR
Italy	Research Site	Roma
Italy	Research Site	Rozzano	MI
Italy	Research Site	Torino	TO
Latvia	Research Site	Riga
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Nilai
Mexico	Research Site	Guadalajara
Mexico	Research Site	Monterrey
Mexico	Research Site	Morelia
Mexico	Research Site	Torreon
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Singapore	Research Site	Singapore
Slovenia	Research Site	Ljubliana
Spain	Research Site	Barcelona
Spain	Research Site	Elche	Alicante
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
Sweden	Research Site	Goteborg
Sweden	Research Site	Luleå
Sweden	Research Site	Örebro
Sweden	Research Site	Östersund
Sweden	Research Site	Skövde
Sweden	Research Site	Stockholm
Sweden	Research Site	Sundsvall
Sweden	Research Site	Umeå
Sweden	Research Site	Vasteras
Switzerland	Research Site	Bellinzona
Switzerland	Research Site	St. Gallen
Switzerland	Research Site	Zürich
Thailand	Research Site	Chiang Mai
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
United States	Research Site	Austin	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boca Raton	Florida
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cleveland	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	South Carolina
United States	Research Site	Dallas	Texas
United States	Research Site	Durham	North Carolina
United States	Research Site	Fairfax	Virginia
United States	Research Site	Fountain Valley	California
United States	Research Site	Great Neck	New York
United States	Research Site	Houston	Texas
United States	Research Site	Knoxville	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	Macon	Georgia
United States	Research Site	Nashville	Tennessee
United States	Research Site	Newark	Delaware
United States	Research Site	Norwich	Connecticut
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Racine	Wisconsin
United States	Research Site	Rochester	New York
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Santa Rosa	California
United States	Research Site	Seattle	Washington
United States	Research Site	Skokie	Illinois
United States	Research Site	St. Louis Park	Minnesota
United States	Research Site	Stockton	California
United States	Research Site	Syracuse	New York
United States	Research Site	Tucker	Georgia
United States	Research Site	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  China,  Croatia,  Denmark,  Estonia,  France,  Germany,  Hong Kong,  Indonesia,  Italy,  Latvia,  Malaysia,  Mexico,  Philippines,  Singapore,  Slovenia,  Spain,  Sweden,  Switzerland,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare overall survival between ZD1839 and docetaxel
Secondary	To compare time to progression (TTP) between ZD1839 and docetaxel
Secondary	To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
Secondary	To compare the overall objective tumor response rate between ZD1839 and docetaxel
Secondary	To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
Secondary	To compare safety and tolerability of ZD1839 and docetaxel