A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00940875
Last Updated: 2015-04-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2009-06-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
erlotinib [Tarceva]
150mg po on days 15-28 of each 4 week cycle
gemcitabine
1250mg/m2/day on days 1 and 8 of each 4 week cycle
2
gemcitabine
1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle
Interventions
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erlotinib [Tarceva]
150mg po on days 15-28 of each 4 week cycle
gemcitabine
1250mg/m2/day on days 1 and 8 of each 4 week cycle
gemcitabine
1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle
Eligibility Criteria
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Inclusion Criteria
* advanced (stage IIIB or IV)non-small cell lung cancer;
* no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.
Exclusion Criteria
* unstable systemic disease.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Port Macquarie, New South Wales, Australia
Randwick, New South Wales, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Tweed Heads, New South Wales, Australia
Wollongong, New South Wales, Australia
Brisbane, Queensland, Australia
Greenslopes, Queensland, Australia
Woolloongabba, Queensland, Australia
Richmond, South Australia, Australia
Terrace Gardens, South Australia, Australia
Hobart, Tasmania, Australia
Bendigo, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Wodonga, Victoria, Australia
Fremantle, Western Australia, Australia
Countries
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Other Identifiers
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ML22429
Identifier Type: -
Identifier Source: org_study_id
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