Clinical trial NCT00388960: Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer
Official title: Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: small cell lung cancer
amrubicin
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 99
Sex: ALL
Minimum age (years): 18
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 document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically/cytologically proven small cell lung cancer
* 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:

* Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0)
* Uncontrolled or severe cardiovascular disease
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Primary outcomes:
measure: Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
timeFrame: Until Disease Progression
Secondary outcomes:
measure: Toxicity
timeFrame: Until 30 days after last protocol treatment
measure: Progression-free survival
timeFrame: Until disease progression or death
measure: Overall survival
timeFrame: Until death
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Algemeen Ziekenhuis Middelheim
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universiteit Gent
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Liege
country: Belgium
facility: Domaine Universitaire du Sart-Tilman
city: Liege
country: Belgium
facility: Centre Hospitalier Regional de la Citadelle
city: Namur
country: Belgium
facility: Clinique Sainte Elisabeth
city: Genova
country: Italy
facility: Instituto Nazionale per la Ricerca sul Cancro
city: Udine
country: Italy
facility: Universita Degli Studi Di Udine
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente - Dept of Pulmonary Diseases
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Zwolle
country: Netherlands
facility: Isala Kliniek
city: Gdansk
country: Poland
facility: Medical University of Gdansk - Dept Radiotherapy
city: Bebington
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
state: Merseyside
city: Dundee
country: United Kingdom
facility: University of Dundee - Ninewells Hospital
state: Scotland
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Hull
country: United Kingdom
facility: Princess Royal Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital, London
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Sir Bobby Robson Cancer Trials Research Centre
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital Lung Unit
Study officials:
affiliation: Royal Marsden Hospital, London, UK
name: Mary O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available.