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

NCT00388960 | Completed Phase 2 DMC

• 2 other identifiers: EORTC Protocol 080622006-001956-11
• Study Type: interventional
• Target: 99
• Locations: 5 countries
• Sites: 25

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; amrubicin

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)

  Until Disease Progression

Secondary Outcomes (3)

• Toxicity

  Until 30 days after last protocol treatment

• Progression-free survival

  Until disease progression or death

• Overall survival

  Until death

Study Arms (3)

Amrubicin

EXPERIMENTAL

Amrubicin 45mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.

Drug: Amrubicin

Amrubicin plus Cisplatin

EXPERIMENTAL

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.

Drug: Amrubicin; Drug: Cisplatin

Cisplatin plus etoposide

ACTIVE COMPARATOR

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.

Drug: Cisplatin; Drug: Etoposide

Interventions

Amrubicin DRUG

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; Amrubicin plus Cisplatin

Cisplatin DRUG

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.

Amrubicin plus Cisplatin; Cisplatin plus etoposide

Etoposide DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (25)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Universiteit Gent

Ghent, 9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, 3000, Belgium

Location

Domaine Universitaire du Sart-Tilman

Liège, 1BE, Belgium

Location

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

Location

Clinique Sainte Elisabeth

Namur, 5000, Belgium

Location

Instituto Nazionale per la Ricerca sul Cancro

Genova, 16132, Italy

Location

Universita Degli Studi Di Udine

Udine, 33100, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

Location

Medisch Spectrum Twente - Dept of Pulmonary Diseases

Enschede, 7500 KA, Netherlands

Location

Leiden University Medical Centre

Leiden, 2300RC, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202, Netherlands

Location

Isala Kliniek

Zwolle, 8001, Netherlands

Location

Medical University of Gdansk - Dept Radiotherapy

Gdansk, 80211, Poland

Location

Clatterbridge Centre for Oncology NHS Trust

Bebington, Merseyside, CH684JY, United Kingdom

Location

University of Dundee - Ninewells Hospital

Dundee, Scotland, D01 9SY, United Kingdom

Location

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Princess Royal Hospital

Hull, HU8 9HE, United Kingdom

Location

Royal Marsden Hospital, London

London, SM2 5PT, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Sir Bobby Robson Cancer Trials Research Centre

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Royal Marsden Hospital Lung Unit

Sutton, (Surrey) SM2 5PT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 21684151 BACKGROUND

• Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available.

  PMID: 30187833 BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

amrubicin; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Mary O'Brien, MD

  Royal Marsden Hospital, London, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 17, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

PL (1); GB (9); IT (2); BE (7); NL (6)