Clinical trial NCT00259064: Iressa v BSC (Best Supportive Care) in First Line NSCLC
Official title: A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC
* NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
* Not suitable for chemotherapy
* WHO Performance status 2 or 3

Exclusion Criteria:

* Newly diagnosed CNS mets
* Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
* Other co-existing malignancies
* ALT/AST greater than 5 x upper limit of normal
* ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Primary outcomes:
measure: To compare Iressa v best supportive care in terms of progression free survival
timeFrame: Progression-free survival
Secondary outcomes:
measure: To compare Iressa v best supportive care in terms of objective tumour response rate
timeFrame: Overall objective tumour response rate (CR and PR) according to the RECIST criteria
measure: To compare Iressa v best supportive care in terms of overall survival
timeFrame: Time to death
measure: To compare Iressa v best supportive care in terms of quality of life
timeFrame: Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score
measure: To compare Iressa v best supportive care in terms of tolerability
timeFrame: Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs
Other outcomes:
measure: To investigate the correlation of the expression of biomarkers in tumour tissue obtained prior to gefitinib therapy with gefitinib clinical efficacy and to determine a set of biomarkers to enable patient selection for therapy.
timeFrame: Efficacy (objective response rate and progression free survival), toxicity, EGFR signalling pathways markers, RNA expression profile, gene polymorphisms of pre specified germline and tumour genes, DNA methylation, plasma and urine proteomics
measure: To compare gefitinib + BSC versus Placebo + BSC in terms of Health Resource Utilisation
timeFrame: The use of selected items of resource and concomitant medications including: number of in patient days, number of out patient visits, number of invasive procedures, pallative radiotherapy, concomitant medications.
measure: To compare gefitinib + BSC versus Placebo + BSC in terms of changes in pain and fatigue
timeFrame: Changes in pain and fatigue as measured by the single items from the FACT-L physical well being domain.
Locations:
city: Bedford Park
country: Australia
facility: Research Site
city: Chermside
country: Australia
facility: Research Site
city: Concord
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Newcastle
country: Australia
facility: Research Site
city: Prahran
country: Australia
facility: Research Site
city: Randwick
country: Australia
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Research Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Nova Ves pod Plesi
country: Czech Republic
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Den Bosch
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
city: Abergavenny
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Iressa Medical Science Director, MD
role: STUDY_DIRECTOR
References: