Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer
NCT ID: NCT00433498
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
846 participants
INTERVENTIONAL
2007-01-31
2013-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized phase III trial is studying etoposide and cisplatin or carboplatin to see how well they work when given as first-line chemotherapy together with pravastatin compared with first-line chemotherapy and a placebo in treating patients with small cell lung cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Compare the survival of patients with small cell lung cancer treated with etoposide phosphate in combination with cisplatin or carboplatin as first-line chemotherapy with vs without pravastatin.
Secondary
* Compare the progression-free survival of patients treated with these regimens.
* Compare the local progression-free survival (local control) of these patients.
* Compare the response rate in these patients.
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (limited stage vs extensive stage), ECOG performance status (0 or 1 vs 2 or 3), and participating site. Patients are randomized to 1 of 2 treatment arms.
All patients receive chemotherapy comprising cisplatin IV or carboplatin IV on day 1 and etoposide phosphate IV on days 1-3 or orally twice daily on days 2 and 3. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm I: Patients receive oral pravastatin daily beginning on day 1 of chemotherapy and continuing for up to 24 months.
* Arm II: Patients receive oral placebo daily beginning on day 1 of chemotherapy and continuing for up to 24 months.
Some patients may undergo blood and urine sample collection at baseline and periodically during and after study treatment. Samples are examined by genetic analysis, metabonomics and proteomics (to detect expression of RAS proteins, phospho-Erk, and other signals downstream of RAS), and cholesterol measurements.
After completion of study treatment, patients are followed every 2 months for 1 year and every 3 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 842 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Carboplatin/cisplatin and Etoposide with Pravastatin
carboplatin
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
cisplatin
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
etoposide phosphate
Day 1: given by IV, days 2 and 3 given by IV or oral. Dose should be given according to local practice but suggested doses and schedules are provided in the protocol.
pravastatin sodium
40mg daily oral tablet taken for a maximum of 2 years
Carboplatin/cisplatin and Etoposide with Placebo
carboplatin
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
cisplatin
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
etoposide phosphate
Day 1: given by IV, days 2 and 3 given by IV or oral. Dose should be given according to local practice but suggested doses and schedules are provided in the protocol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
carboplatin
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
cisplatin
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
etoposide phosphate
Day 1: given by IV, days 2 and 3 given by IV or oral. Dose should be given according to local practice but suggested doses and schedules are provided in the protocol.
pravastatin sodium
40mg daily oral tablet taken for a maximum of 2 years
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed small cell lung cancer
* Limited stage or extensive stage disease
* No mixed cell histology
* No symptomatic brain metastases that require immediate radiotherapy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Life expectancy \> 8 weeks
* Platelet count \> 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count \> 1,500/mm\^3
* Glomerular filtration rate ≥ 50 mL/min
* Creatine kinase ≤ 5 times upper limit of normal (ULN)
* Liver function tests (ALP, ALT/AST, and bilirubin) \< 3 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 1 year after completion of chemotherapy/radiotherapy and for an additional 28 days after completion of pravastatin sodium
* Able to tolerate chemotherapy
* No evidence of significant medical condition or laboratory finding that, in the opinion of the investigator, would preclude study participation
* No family history of hypercholesterolemia
* No history of malignant tumor unless the patient has been without evidence of disease for ≥ 3 years or tumor was a nonmelanoma skin tumor or early cervical cancer
PRIOR CONCURRENT THERAPY:
* More than 12 months since prior statin
* More than 4 weeks since prior fibrates (e.g., bezofibrate, gemfibrozil, or fenofibrate)
* No prior chemotherapy for this cancer
* No prior radiotherapy for this cancer unless to distant metastases (i.e., not within the thorax or thoracic/cervical spine area)
* No concurrent cyclosporine
* Concurrent radiotherapy allowed
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael J. Seckl, MD, PhD
Role: STUDY_CHAIR
Charing Cross Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
William Harvey Hospital
Ashford-Kent, England, United Kingdom
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
North Devon District Hospital
Barnstaple, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom
Sandwell General Hospital
Birmingham, England, United Kingdom
Good Hope Hospital
Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Bradford Royal Infirmary
Bradford, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Queen's Hospital
Burton-on-Trent, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Broomfield Hospital
Chelmsford, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Queen Alexandra Hospital
Cosham, England, United Kingdom
Darent Valley Hospital
Dartford Kent, England, United Kingdom
Royal Derby Hospital
Derby, England, United Kingdom
Dorset County Hospital
Dorchester, England, United Kingdom
University Hospital of North Durham
Durham, England, United Kingdom
Princess Alexandra Hospital
Essex, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Harrogate District Hospital
Harrogate, England, United Kingdom
Hereford Hospitals
Hereford, England, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom
Castle Hill Hospital
Hull, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Airedale General Hospital
Keighley, England, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, England, United Kingdom
Cancer Research UK Clinical Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
University College Hospital
London, England, United Kingdom
Guy's Hospital
London, England, United Kingdom
Queen Elizabeth Hospital - Woolwich
London, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Charing Cross Hospital
London, England, United Kingdom
Luton and Dunstable Hospital
Luton, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Wythenshawe Hospital
Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Milton Keynes General Hospital
Milton Keynes, England, United Kingdom
Freeman Hospital
Newcastle upon Tyne, England, United Kingdom
St. Mary's Hospital
Newport, England, United Kingdom
Friarage Hospital
North Yorks, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Northampton General Hospital
Nottingham, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
King's Mills Hospital
Nottinghamshire, England, United Kingdom
Princess Royal University Hospital
Orpington, Kent, England, United Kingdom
Peterborough Hospitals Trust
Peterborough, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom
Salisbury District Hospital
Salisbury, England, United Kingdom
Scarborough General Hospital
Scarborough, England, United Kingdom
Scunthorpe General Hospital
Scunthorpe, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
South Tyneside District Hospital
South Shields, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Lister Hospital
Stevenage, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Walsall Manor Hospital
Walsall, England, United Kingdom
Weston General Hospital
Weston-super-Mare, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Worcestershire Royal Hospital
Worcester, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Cancer Care Centre at York Hospital
York, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Falkirk and District Royal Infirmary
Falkirk, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Llandough Hospital
Cardiff, Wales, United Kingdom
Nevill Hall Hospital
Gwent, Wales, United Kingdom
Withybush General Hospital
Haverfordwest, Wales, United Kingdom
Royal Gwent Hospital
Newport Gwent, Wales, United Kingdom
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Singleton Hospital
Swansea, Wales, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRUK-LUNGSTAR
Identifier Type: -
Identifier Source: secondary_id
EU-20649
Identifier Type: -
Identifier Source: secondary_id
ISRCTN56306957
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-005821-71
Identifier Type: -
Identifier Source: secondary_id
UCL-BRD/05/129
Identifier Type: -
Identifier Source: secondary_id
MREC-06-MRE10-28
Identifier Type: -
Identifier Source: secondary_id
CTA-20363-0215-001
Identifier Type: -
Identifier Source: secondary_id
CTAAC-C1312-A5335
Identifier Type: -
Identifier Source: secondary_id
CTAAC-C1312-A12462
Identifier Type: -
Identifier Source: secondary_id
CDR0000531141
Identifier Type: -
Identifier Source: org_study_id