Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer
NCT ID: NCT00388960
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2006-11-01
2010-12-01
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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Amrubicin
Amrubicin 45mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Amrubicin
Amrubicin 45mg/m\<2\> IV days 1, 2 3 of each 21-day cycle until disease progression.
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
Amrubicin plus Cisplatin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> IV day 1 of each 21-day cycle until disease progression.
Amrubicin
Amrubicin 45mg/m\<2\> IV days 1, 2 3 of each 21-day cycle until disease progression.
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
Cisplatin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus Cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Cisplatin plus etoposide
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 each 21-day cycle until disease progression.
Cisplatin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus Cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Etoposide
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Interventions
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Amrubicin
Amrubicin 45mg/m\<2\> IV days 1, 2 3 of each 21-day cycle until disease progression.
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
Cisplatin
Amrubicin 40mg/m\<2\> IV days 1, 2, 3 plus Cisplatin 60mg/m\<2\> day 1 of each 21-day cycle until disease progression.
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Etoposide
Cisplatin 75mg/m\<2\> IV day 1 plus etoposide 100mg/m\<2\> IV day 1 and 200mg/m\<2\> orally days 2, 3 or etoposide 100mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Eligibility Criteria
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Inclusion Criteria
* Extensive disease
* Measurable disease
* World Health Organization (WHO) performance status 0-2
* Age 18 years or older
* Normal baseline cardiac function
* No prior systemic chemotherapy for small cell lung cancer
* Adequate organ function including bone marrow, kidney, and liver
* No history of interstitial lung disease or pulmonary fibrosis
* No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
* No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception
* Written informed consent before randomization
Exclusion Criteria
* Uncontrolled or severe cardiovascular disease
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Mary O'Brien, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden Hospital, London, UK
Locations
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Algemeen Ziekenhuis Middelheim
Antwerp, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universiteit Gent
Ghent, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Domaine Universitaire du Sart-Tilman
Liège, , Belgium
Centre Hospitalier Regional de la Citadelle
Liège, , Belgium
Clinique Sainte Elisabeth
Namur, , Belgium
Instituto Nazionale per la Ricerca sul Cancro
Genova, , Italy
Universita Degli Studi Di Udine
Udine, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Medisch Spectrum Twente - Dept of Pulmonary Diseases
Enschede, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Isala Kliniek
Zwolle, , Netherlands
Medical University of Gdansk - Dept Radiotherapy
Gdansk, , Poland
Clatterbridge Centre for Oncology NHS Trust
Bebington, Merseyside, United Kingdom
University of Dundee - Ninewells Hospital
Dundee, Scotland, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Princess Royal Hospital
Hull, , United Kingdom
Royal Marsden Hospital, London
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital Lung Unit
Sutton, , United Kingdom
Countries
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References
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O'Brien ME, Konopa K, Lorigan P, Bosquee L, Marshall E, Bustin F, Margerit S, Fink C, Stigt JA, Dingemans AM, Hasan B, Van Meerbeeck J, Baas P. Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. Eur J Cancer. 2011 Oct;47(15):2322-30. doi: 10.1016/j.ejca.2011.05.020. Epub 2011 Jun 16.
Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available.
Other Identifiers
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2006-001956-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EORTC Protocol 08062
Identifier Type: -
Identifier Source: org_study_id
NCT00424073
Identifier Type: -
Identifier Source: nct_alias
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