Small Cell Lung CancerPhase 2NCT00388960
Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing Amrubicin, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by Celgene at 25 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Amrubicin, Cisplatin and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 1 Nov 2006to 1 Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United Kingdom9 sites
Clatterbridge Centre for Oncology NHS Trust
Bebington, Merseyside, CH684JY
Belfast City Hospital
Belfast, BT9 7AB
University of Dundee - Ninewells Hospital
Dundee, Scotland, D01 9SY
Western General Hospital
Edinburgh, EH4 2XU
Princess Royal Hospital
Hull, HU8 9HE
Royal Marsden Hospital, London
London, SM2 5PT
Christie Hospital
Manchester, M20 4BX
Sir Bobby Robson Cancer Trials Research Centre
Newcastle upon Tyne, NE4 6BE
Royal Marsden Hospital Lung Unit
Sutton, (Surrey) SM2 5PT
Belgium7 sites
Algemeen Ziekenhuis Middelheim
Antwerp, 2020
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universiteit Gent
Ghent, 9000
U.Z. Gasthuisberg
Leuven, 3000
Domaine Universitaire du Sart-Tilman
Liège, 1BE
Centre Hospitalier Regional de la Citadelle
Liège, 4000
Clinique Sainte Elisabeth
Namur, 5000
Netherlands6 sites
Academisch Medisch Centrum
Amsterdam, 1105 AZ
The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis
Amsterdam
Medisch Spectrum Twente - Dept of Pulmonary Diseases
Enschede, 7500 KA
Leiden University Medical Centre
Leiden, 2300RC
Academisch Ziekenhuis Maastricht
Maastricht, 6202
Isala Kliniek
Zwolle, 8001
Italy2 sites
Instituto Nazionale per la Ricerca sul Cancro
Genova, 16132
Universita Degli Studi Di Udine
Udine, 33100
About this study
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)
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
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmrubicinDrug
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.
CisplatinDrug
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.
EtoposideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Amrubicin | Experimental | Amrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression. Receives: 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. Receives: 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. Receives: Drug: Cisplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Measured: Until Disease Progression
Secondary outcomes (3)
Toxicity
Measured: Until 30 days after last protocol treatment
Progression-free survival
Measured: Until disease progression or death
Overall survival
Measured: Until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study start1 Nov 2006
- Primary completion1 Apr 2010
- Study completion1 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary O'Brien, MD, Principal investigator, Royal Marsden Hospital, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388960
- Sponsor's protocol ID
- EORTC Protocol 08062
- Other IDs
- 2006-001956-11
- Status last verified
- Nov 2019
- First submitted
- 13 Oct 2006
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21684151Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available.
PubMed 30187833
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00388960
- Acronym / sponsor ID
- EORTC Protocol 08062
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer, amrubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2006 (actual)
- Primary completion
- 1 Apr 2010 (actual)
- Study completion
- 1 Dec 2010 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amrubicin | Experimental | Drug: AmrubicinAmrubicin 45mg/m<2> IV days 1, 2, 3 of each 21-day cycle until disease progression. |
| Amrubicin plus Cisplatin | Experimental | Drug: Amrubicin, Drug: CisplatinAmrubicin 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 | Active comparator | Drug: Cisplatin, Drug: EtoposideCisplatin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically/cytologically proven small cell lung cancer
- Extensive disease
- Measurable disease
- World Health Organization (WHO) performance status 0-2
- Age 18 years or older
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmrubicinAmrubicin 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 | Amrubicin, Amrubicin plus Cisplatin |
| CisplatinAmrubicin 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. | Drug | Amrubicin plus Cisplatin, Cisplatin plus etoposide |
| EtoposideCisplatin 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. | Drug | Cisplatin plus etoposide |
Primary outcome
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)
Time frame: Until Disease Progression
3 secondary outcomes
Toxicity
Time frame: Until 30 days after last protocol treatment
Progression-free survival
Time frame: Until disease progression or death
Overall survival
Time frame: Until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 21684151O'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.
- Background: PubMed 30187833Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary O'Brien, MD principal investigator
Royal Marsden Hospital, London, UK
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amrubicin, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by Celgene at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom, Belgium, Netherlands, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks) (time frame: Until Disease Progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00388960, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.