search
Back to results

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

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Amrubicin
Cisplatin
Etoposide
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring small cell lung cancer, amrubicin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Algemeen Ziekenhuis Middelheim
  • Universitair Ziekenhuis Antwerpen
  • Universiteit Gent
  • U.Z. Gasthuisberg
  • Domaine Universitaire du Sart-Tilman
  • Centre Hospitalier Regional de la Citadelle
  • Clinique Sainte Elisabeth
  • Instituto Nazionale per la Ricerca sul Cancro
  • Universita Degli Studi Di Udine
  • Academisch Medisch Centrum
  • The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis
  • Medisch Spectrum Twente - Dept of Pulmonary Diseases
  • Leiden University Medical Centre
  • Academisch Ziekenhuis Maastricht
  • Isala Kliniek
  • Medical University of Gdansk - Dept Radiotherapy
  • Clatterbridge Centre for Oncology NHS Trust
  • University of Dundee - Ninewells Hospital
  • Belfast City Hospital
  • Western General Hospital
  • Princess Royal Hospital
  • Royal Marsden Hospital, London
  • Christie Hospital
  • Sir Bobby Robson Cancer Trials Research Centre
  • Royal Marsden Hospital Lung Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Amrubicin

Amrubicin plus Cisplatin

Cisplatin plus etoposide

Arm Description

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> IV 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 each 21-day cycle until disease progression.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity
Progression-free survival
Overall survival

Full Information

First Posted
October 13, 2006
Last Updated
November 14, 2019
Sponsor
Celgene
search

1. Study Identification

Unique Protocol Identification Number
NCT00388960
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2006 (Actual)
Primary Completion Date
April 1, 2010 (Actual)
Study Completion Date
December 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
small cell lung cancer, amrubicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amrubicin
Arm Type
Experimental
Arm Description
Amrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression.
Arm Title
Amrubicin plus Cisplatin
Arm Type
Experimental
Arm Description
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.
Arm Title
Cisplatin plus etoposide
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amrubicin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Time Frame
Until Disease Progression
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
Until 30 days after last protocol treatment
Title
Progression-free survival
Time Frame
Until disease progression or death
Title
Overall survival
Time Frame
Until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary O'Brien, MD
Organizational Affiliation
Royal Marsden Hospital, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universiteit Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Domaine Universitaire du Sart-Tilman
City
Liege
ZIP/Postal Code
1BE
Country
Belgium
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Instituto Nazionale per la Ricerca sul Cancro
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Universita Degli Studi Di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis
City
Amsterdam
Country
Netherlands
Facility Name
Medisch Spectrum Twente - Dept of Pulmonary Diseases
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
Leiden University Medical Centre
City
Leiden
ZIP/Postal Code
2300RC
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202
Country
Netherlands
Facility Name
Isala Kliniek
City
Zwolle
ZIP/Postal Code
8001
Country
Netherlands
Facility Name
Medical University of Gdansk - Dept Radiotherapy
City
Gdansk
ZIP/Postal Code
80211
Country
Poland
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Bebington
State/Province
Merseyside
ZIP/Postal Code
CH684JY
Country
United Kingdom
Facility Name
University of Dundee - Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
D01 9SY
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Hull
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Royal Marsden Hospital, London
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Sir Bobby Robson Cancer Trials Research Centre
City
Newcastle-Upon-Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Royal Marsden Hospital Lung Unit
City
Sutton
ZIP/Postal Code
(Surrey) SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21684151
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.
Results Reference
background
PubMed Identifier
30187833
Citation
Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs