Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388960
• Other study ID #: EORTC Protocol 08062
• Secondary ID: 2006-001956-11
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2006
• Est. completion date: December 1, 2010

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00424073

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 1, 2010
• Est. primary completion date: April 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerpen
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universiteit Gent	Gent
Belgium	U.Z. Gasthuisberg	Leuven
Belgium	Centre Hospitalier Regional de la Citadelle	Liege
Belgium	Domaine Universitaire du Sart-Tilman	Liege
Belgium	Clinique Sainte Elisabeth	Namur
Italy	Instituto Nazionale per la Ricerca sul Cancro	Genova
Italy	Universita Degli Studi Di Udine	Udine
Netherlands	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
Poland	Medical University of Gdansk - Dept Radiotherapy	Gdansk
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Bebington	Merseyside
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	University of Dundee - Ninewells Hospital	Dundee	Scotland
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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Poland,  United Kingdom, 

References & Publications (2)

Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)		Until Disease Progression
Secondary	Toxicity		Until 30 days after last protocol treatment
Secondary	Progression-free survival		Until disease progression or death
Secondary	Overall survival		Until death