Plain English Summary
Trial website
Additional identifiers
EudraCT number
2005-005821-71
ClinicalTrials.gov number
NCT00433498
Protocol/serial number
BRD/05/129
Study information
Scientific title
A multicentre, phase III, randomised, double-blind, placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancer
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 measure
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 (if study stopped)
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
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 organizations
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
Basic results (scientific)
See https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-005821-71/results
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28240967