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

Phase 2

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Amrubicin; Drug: Cisplatin; Drug: Etoposide

• Registration Number: NCT00388960
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-13
• Study First Submitted QC: 2006-10-13
• Study First Posted: 2006-10-17
• Study Start: 2006-11-01
• Primary Completion: 2010-04-01
• Study Completion: 2010-12-01
• Disposition First Submitted: 2012-05-31
• Disposition First Submitted QC: 2012-05-31
• Disposition First Posted: 2012-06-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)	Until Disease Progression

Secondary Outcome Measures

Name	Time	Method
Toxicity	Until 30 days after last protocol treatment
Overall survival	Until death
Progression-free survival	Until disease progression or death

Trial Locations

Locations (25)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Medisch Spectrum Twente - Dept of Pulmonary Diseases; 🇳🇱 Enschede, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Medical University of Gdansk - Dept Radiotherapy; 🇵🇱 Gdansk, Poland

University of Dundee - Ninewells Hospital; 🇬🇧 Dundee, Scotland, United Kingdom

Algemeen Ziekenhuis Middelheim; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Universiteit Gent; 🇧🇪 Gent, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Domaine Universitaire du Sart-Tilman; 🇧🇪 Liege, Belgium

Universita Degli Studi Di Udine; 🇮🇹 Udine, Italy

Centre Hospitalier Regional de la Citadelle; 🇧🇪 Liege, Belgium

Instituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genova, Italy

The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis; 🇳🇱 Amsterdam, Netherlands

Clinique Sainte Elisabeth; 🇧🇪 Namur, Belgium

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands

Isala Kliniek; 🇳🇱 Zwolle, Netherlands

Clatterbridge Centre for Oncology NHS Trust; 🇬🇧 Bebington, Merseyside, 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

Royal Marsden Hospital Lung Unit; 🇬🇧 Sutton, United Kingdom

Christie Hospital; 🇬🇧 Manchester, United Kingdom

Sir Bobby Robson Cancer Trials Research Centre; 🇬🇧 Newcastle-Upon-Tyne, United Kingdom