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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00036647
Registration number
NCT00036647
Ethics application status
Date submitted
13/05/2002
Date registered
14/05/2002
Date last updated
10/01/2018
Titles & IDs
Public title
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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Scientific title
A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
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Secondary ID [1]
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BR.21
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-small-cell Lung
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.
* Must have evidence of disease (clinical or radiological).
* Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.
* If the patient has had surgery, the surgery was at least 2 weeks ago.
* Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.
* If the patient received radiation therapy, treatment was at least 4 weeks ago.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/01/2004
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Sample size
Target
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Accrual to date
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Final
731
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital- Australia - Woden
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Prince of Wales Hospital - Randwick
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Newcastle Mater Misericordiae Hospital - Waratah
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Southern Medical Day Care Center - Wollongong
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Western Hospital - Footscray
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The Royal Melbourne Hospital - Parkville
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Sir Charles Gairdner Hospital - Nedlands
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Royal Adelaide Hospital - South Australia
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Peter MacCallum Cancer Institute - Victoria
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Recruitment hospital [10]
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Austin & Repatriation Medical Centre - Victoria
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2605 - Woden
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2031 - Randwick
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2289 - Waratah
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2500 - Wollongong
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Recruitment postcode(s) [5]
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3011 - Footscray
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3050 - Parkville
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6009 - Nedlands
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5000 - South Australia
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3002 - Victoria
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Recruitment postcode(s) [10]
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3084 - Victoria
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Recruitment outside Australia
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Illinois
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Chiangmai
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
OSI Pharmaceuticals
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Cancer Trials Group
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
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Trial website
https://clinicaltrials.gov/study/NCT00036647
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Trial related presentations / publications
Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753. Tsao MS, Sakurada A, Cutz JC, Zhu CQ, Kamel-Reid S, Squire J, Lorimer I, Zhang T, Liu N, Daneshmand M, Marrano P, da Cunha Santos G, Lagarde A, Richardson F, Seymour L, Whitehead M, Ding K, Pater J, Shepherd FA. Erlotinib in lung cancer - molecular and clinical predictors of outcome. N Engl J Med. 2005 Jul 14;353(2):133-44. doi: 10.1056/NEJMoa050736. Erratum In: N Engl J Med. 2006 Oct 19;355(16):1746.
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Public notes
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Contacts
Principal investigator
Name
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Frances Shephard, M.D.
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Address
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Princess Margaret Hospital, Canada
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00036647
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