Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00433498
- Lead Sponsor
- University College, London
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by making tumor cells more sensitive to chemotherapy. It is not yet known whether etoposide and cisplatin or carboplatin are more effective with or without pravastatin in treating small cell lung cancer.
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
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 846
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carboplatin/cisplatin and Etoposide with Placebo etoposide phosphate - Carboplatin/cisplatin and Etoposide with Pravastatin carboplatin - Carboplatin/cisplatin and Etoposide with Pravastatin etoposide phosphate - Carboplatin/cisplatin and Etoposide with Pravastatin pravastatin sodium - Carboplatin/cisplatin and Etoposide with Pravastatin cisplatin - Carboplatin/cisplatin and Etoposide with Placebo carboplatin - Carboplatin/cisplatin and Etoposide with Placebo cisplatin -
- Primary Outcome Measures
Name Time Method Survival Reported at death.
- Secondary Outcome Measures
Name Time Method Response rate as measured by RECIST criteria after course 3 Post chemo cycle 3 Local progression-free survival (local control) Time until the date of disease progression Progression-free survival Time until the date of disease progression Toxicity as measured by CTCAE version 3.0 At every clinic visit or if serious, an SAE form shoudl be submitted
Trial Locations
- Locations (86)
Walsall Manor Hospital
🇬🇧Walsall, England, United Kingdom
Weston General Hospital
🇬🇧Weston-super-Mare, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Royal Derby Hospital
🇬🇧Derby, England, United Kingdom
Darent Valley Hospital
🇬🇧Dartford Kent, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Airedale General Hospital
🇬🇧Keighley, 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
Queen Elizabeth Hospital - Woolwich
🇬🇧London, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
St. Mary's Hospital
🇬🇧Newport, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Scarborough General Hospital
🇬🇧Scarborough, England, United Kingdom
South Tyneside District Hospital
🇬🇧South Shields, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Falkirk and District Royal Infirmary
🇬🇧Falkirk, Scotland, United Kingdom
Nevill Hall Hospital
🇬🇧Gwent, Wales, United Kingdom
Llandough Hospital
🇬🇧Cardiff, 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
City Hospital - Birmingham
🇬🇧Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Sandwell General Hospital
🇬🇧Birmingham, England, United Kingdom
Good Hope Hospital
🇬🇧Birmingham, England, United Kingdom
William Harvey Hospital
🇬🇧Ashford-Kent, England, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
University Hospital of North Durham
🇬🇧Durham, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧King's Lynn, England, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Milton Keynes General Hospital
🇬🇧Milton Keynes, England, United Kingdom
Lister Hospital
🇬🇧Stevenage, England, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Freeman Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom
Princess Royal University Hospital
🇬🇧Orpington, Kent, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Royal United Hospital
🇬🇧Bath, 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
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Princess Alexandra Hospital
🇬🇧Essex, 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
Luton and Dunstable Hospital
🇬🇧Luton, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Friarage Hospital
🇬🇧North Yorkshire, England, United Kingdom
King's Mills Hospital
🇬🇧Nottinghamshire, England, United Kingdom
Northampton General Hospital
🇬🇧Nottingham, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, England, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom
Castle Hill Hospital
🇬🇧Hull, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom