Condition category
Cancer
Date applied
07/04/2006
Date assigned
08/05/2006
Last edited
29/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Michael Seckl

ORCID ID

Contact details

Department of Medical Oncology
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00433498

Protocol/serial number

BRD/05/129

Study information

Scientific title

Acronym

LungStar

Study hypothesis

To see if the addition of pravastatin to standard combination chemotherapy (cisplatin and etoposide or carboplatin and etoposide) improves response rates, time to disease progression, and survival in patients with Small Cell Lung Cancer (SCLC).

On 15/02/2011 the following changes were made to the trial record:
1. The anticipated end date was changed from 30/04/2010 to 31/10/2011.
2. The target number of participants was changed from 1300 to 860.

Ethics approval

Multicentre Research Ethics Committee for Scotland, 19/04/2006, ref: 06/MRE10/28

Study design

Multicentre phase III randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Small cell lung cancer

Intervention

All patients receive standard chemotherapy: Cisplatin/Etoposide or Carboplatin/Etoposide. They are then randomised prior to or within one working day of starting chemotherapy to:

1. Pravastatin daily for two years
2. Placebo daily for two years

Assessments with each cycle of chemotherapy then, follow up post chemotherapy, two monthly to one year from randomisation then three monthly thereafter.

Intervention type

Drug

Phase

Phase III

Drug names

Pravastatin, cisplatin, carboplatin, etoposide

Primary outcome measures

To determine in patients with SCLC if survival is affected by the addition of pravastatin to either cisplatin/etoposide or carboplatin/etoposide

Secondary outcome measures

To compare the treatments in terms of:
1. Progression-free survival
2. Local progression-free survival (local control)
3. Response rates
4. Toxicity

Overall trial start date

01/06/2006

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically confirmed SCLC
2. Limited or extensive disease
3. Performance status Eastern Cooperative Oncology Group (ECOG) zero to three
4. Life expectancy more than 8 weeks
5. Age 18 or over
6. Willing and able to give informed consent
7. Patient considered able to tolerate chemotherapy
8. Adequate renal function - defined by glomerular filtration rate (GFR) more than 50 ml/min if measured by EthyleneDiamineTetraacetic Acid (EDTA) or GFR more than 40 ml/min if measured by the Cockcroft and Gault (C & G) formula. Cisplatin and etoposide dose should be modified according to renal function as per dose modification schedule.
9. Adequate bone marrow reserve - Absolute Neutrophil Count (ANC) more than 1.5 x 10^9 /l, Haemoglobin (Hb) more than 10.0 g/dl and platelet count more than 100 x 10^9 /l
10. Liver function tests less than three times Upper Limit of Normal (ULN)
11. Creatine Kinase less than or equal to five times ULN

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

860

Participant exclusion criteria

1. Prior chemotherapy for this disease (protocol chemotherapy should start after randomisation except for where a patient needs to start chemotherapy urgently, randomisation may occur a maximum of one working day after day one of cycle one)
2. Prior radiotherapy for this disease (except for prior radiotherapy to distant metastases i.e. not within the thorax or thoracic or cervical spine is acceptable)
3. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
4. Patients with a family history of hypercholesterolaemia
5. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years or the tumour was a non-melanoma skin tumour or early cervical cancer
6. Patients treated with fibrates e.g. bezofibrate, gemfibrozil, fenofibrate within four weeks prior to randomisation
7. Patients on cyclosporin
8. Patients with symptomatic brain metastases, which require immediate radiotherapy
9. Pregnancy and lactation. Effective contraception is mandatory for all patients of reproductive potential if sexually active whilst in the study. Contraception should continue for one year post-completion of all chemotherapy or radiotherapy and a further 28 days after cessation of pravastatin or placebo
10. Treatment with any statin within previous 12 months

Recruitment start date

01/06/2006

Recruitment end date

31/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medical Oncology
London
W6 8RF
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C1312/A5335)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes