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

Sponsor:	Celgene Corporation
Information provided by (Responsible Party):	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00388960

Purpose

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.

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: Amrubicin Drug: Cisplatin Drug: Etoposide	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks) [ Time Frame: Until Disease Progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Time Frame: Until 30 days after last protocol treatment ] [ Designated as safety issue: Yes ]
Progression-free survival [ Time Frame: Until disease progression or death ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Until death ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	November 2006
Study Completion Date:	December 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Amrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.	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.
Experimental: 2 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 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. Drug: 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.
Active Comparator: 3 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: 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically/cytologically proven small cell lung cancer
Extensive disease
Measurable disease
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388960

Locations

Belgium
Algemeen Ziekenhuis Middelheim
Antwerpen, Belgium, 2020
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Universiteit Gent
Gent, Belgium, 9000
U.Z. Gasthuisberg
Leuven, Belgium, 3000
Centre Hospitalier Regional de la Citadelle
Liege, Belgium, 4000
Domaine Universitaire du Sart-Tilman
Liege, Belgium, 1BE
Clinique Sainte Elisabeth
Namur, Belgium, 5000
Italy
Instituto Nazionale per la Ricerca sul Cancro
Genova, Italy, 16132
Universita Degli Studi Di Udine
Udine, Italy, 33100
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis
Amsterdam, Netherlands
Medisch Spectrum Twente - Dept of Pulmonary Diseases
Enschede, Netherlands, 7500 KA
Leiden University Medical Centre
Leiden, Netherlands, 2300RC
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202
Isala Kliniek
Zwolle, Netherlands, 8001
Poland
Medical University of Gdansk - Dept Radiotherapy
Gdansk, Poland, 80211
United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Bebington, Merseyside, United Kingdom, CH684JY
University of Dundee - Ninewells Hospital
Dundee, Scotland, United Kingdom, D01 9SY
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Princess Royal Hospital
Hull, United Kingdom, HU8 9HE
Royal Marsden Hospital, London
London, United Kingdom, SM2 5PT
Christie Hospital
Manchester, United Kingdom, M20 4BX
Sir Bobby Robson Cancer Trials Research Centre
Newcastle-Upon-Tyne, United Kingdom, NE4 6BE
Royal Marsden Hospital Lung Unit
Sutton, United Kingdom, (Surrey) SM2 5PT

Sponsors and Collaborators

Celgene Corporation

Investigators

Principal Investigator:

Mary O'Brien, MD

Royal Marsden Hospital, London, UK

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00388960 History of Changes
Obsolete Identifiers:	NCT00424073
Other Study ID Numbers:	EORTC 08062, EudraCT Number 2006-001956-11
Study First Received:	October 13, 2006
Last Updated:	April 9, 2012
Health Authority:	European Union: European Medicines Agency

Keywords provided by Celgene Corporation:

small cell lung cancer
amrubicin

Additional relevant MeSH terms:

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

Etoposide phosphate
Amrubicin
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 24, 2012