Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University College Hospital - London

Michael J. Seckl

Study Chair

United Kingdom
England
	Ashford-Kent
	William Harvey Hospital
		Contact Person	Ph: 44-1227-766-877
	Aylesbury-Buckinghamshire
	Stoke Mandeville Hospital
		Contact Person	Ph: 44-1296-315-319
	Barnstaple
	North Devon District Hospital
		Contact Person	Ph: 44-1271-311-584
	Bath
	Royal United Hospital
		Contact Person	Ph: 44-1225-825-096
	Birmingham
	Birmingham Heartlands Hospital
		Contact Person	Ph: 44-1214-241-146
	City Hospital - Birmingham
		Contact Person	Ph: 44-1215-075-129
	Good Hope Hospital
		Contact Person	Ph: 44-1214-249-240
	Sandwell General Hospital
		Contact Person	Ph: 44-1215-075-129
	Bournemouth
	Royal Bournemouth Hospital
		Contact Person	Ph: 44-1202-704-773
	Bradford
	Bradford Royal Infirmary
		Contact Person	Ph: 44-1274-383-432
	Brighton
	Sussex Cancer Centre at Royal Sussex County Hospital
		Contact Person	Ph: 44-1273-696-955
	Burton-upon-Trent
	Queen's Hospital
		Contact Person	Ph: 44-1283-566-333
	Cambridge
	Addenbrooke's Hospital
		Contact Person	Ph: 44-1223-216-083
	Canterbury
	Kent and Canterbury Hospital
		Contact Person	Ph: 44-1227-766-877
	Chelmsford
	Broomfield Hospital
		Contact Person	Ph: 44-1245-516-048
	Cheltenham
	Gloucestershire Oncology Centre at Cheltenham General Hospital
		Contact Person	Ph: 44-8454-223-445
	Colchester
	Essex County Hospital
		Contact Person	Ph: 44-1206-744-496
	Cosham
	Queen Alexandra Hospital
		Contact Person	Ph: 44-2392-284-811
	Dartford Kent
	Darent Valley Hospital
		Contact Person	Ph: 44-1322-428-100
	Derby
	Derbyshire Royal Infirmary
		Contact Person	Ph: 44-1332-787-985
	Dorchester
	Dorset County Hospital
		Contact Person	Ph: 44-1305-255-253
	Durham
	University Hospital of North Durham
		Contact Person	Ph: 44-1913-332-659
	Essex
	Princess Alexandra Hospital
		Contact Person	Ph: 44-1279-694-920
	Exeter
	Royal Devon and Exeter Hospital
		Contact Person	Ph: 44-1392-402-171
	Gloucester
	Gloucestershire Royal Hospital
		Contact Person	Ph: 44-8454-223-445
	Grimsby
	Diana Princess of Wales Hospital
		Contact Person	Ph: 44-1472-875-707
	Guildford
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Contact Person	Ph: 44-1483-571-122
	Harrogate
	Harrogate District Hospital
		Contact Person	Ph: 44-1423-554-457
	Hereford
	Hereford Hospitals
		Contact Person	Ph: 44-1432-355-444
	High Wycombe
	Wycombe General Hospital
		Contact Person	Ph: 44-1296-315-908
	Huddersfield, West Yorks
	Huddersfield Royal Infirmary
		Contact Person	Ph: 44-1484-342-905
	Hull
	Castle Hill Hospital
		Contact Person	Ph: 44-1482-676-569
	Ipswich
	Ipswich Hospital
		Contact Person	Ph: 44-1473-704-389
	Keighley
	Airedale General Hospital
		Contact Person	Ph: 44-1535-292-838
	King's Lynn
	Queen Elizabeth Hospital
		Contact Person	Ph: 44-1553-613-532
	Leeds
	Cancer Research UK Clinical Centre at St. James's University Hospital
		Contact Person	Ph: 44-1132-067-727
	Leicester
	Leicester Royal Infirmary
		Contact Person	Ph: 44-1162-586-078
	London
	Charing Cross Hospital
		Michael J. Seckl, MD, PhD	Ph: 44-20-8846-1421
	Guy's Hospital
		Contact Person	Ph: 44-2071-882-006
	Queen Elizabeth Hospital - Woolwich
		Contact Person	Ph: 44-1689-863-817
	St. George's Hospital
		Contact Person	Ph: 44-2087-250-542
	University College Hospital
		Contact Person	Ph: 44-8451-555-000
	Luton
	Luton and Dunstable Hospital
		Contact Person	Ph: 44-1582-718-292
	Maidstone
	Maidstone Hospital
		Contact Person	Ph: 44-1622-227-078
	Manchester
	Christie Hospital
		Contact Person	Ph: 44-1614-468-406
	Wythenshawe Hospital
		Contact Person	Ph: 44-1612-915-041
	Margate
	Queen Elizabeth The Queen Mother Hospital
		Contact Person	Ph: 44-1227-866-393
	Middlesbrough
	James Cook University Hospital
		Contact Person	Ph: 44-1642-854-091
	Milton Keynes
	Milton Keynes General Hospital
		Contact Person	Ph: 44-1908-826-638
	Newcastle-Upon-Tyne
	Freeman Hospital
		Contact Person	Ph: 44-1912-138-439
	Newport
	St. Mary's Hospital
		Christopher Baughan, MD	Ph: 44-1983-524-081
	North Yorkshire
	Friarage Hospital
		Contact Person	Ph: 44-1642-282-516
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Contact Person	Ph: 44-1923-844-109
	Nottingham
	Northampton General Hospital
		Contact Person	Ph: 44-1604-523-536
	Nottingham City Hospital
		Contact Person	Ph: 44-1159-691-169
	Nottinghamshire
	King's Mills Hospital
		Contact Person	Ph: 44-1623-672-440
	Orpington, Kent
	Princess Royal University Hospital
		Contact Person	Ph: 44-1689-863-817
	Peterborough
	Peterborough Hospitals Trust
		Contact Person	Ph: 44-1733-678-000
	Plymouth
	Derriford Hospital
		Contact Person	Ph: 44-1752-431-960
	Poole Dorset
	Dorset Cancer Centre
		Contact Person	Ph: 44-1202-448-318
	Reading
	Berkshire Cancer Centre at Royal Berkshire Hospital
		Contact Person	Ph: 44-1183-227-898
	Salisbury
	Salisbury District Hospital
		Contact Person	Ph: 44-1722-429-191
	Scarborough
	Scarborough General Hospital
		Contact Person	Ph: 44-1723-342-175
	Scunthorpe
	Scunthorpe General Hospital
		Contact Person	Ph: 44-1724-282-282
	Shrewsbury
	Royal Shrewsbury Hospital
		Contact Person	Ph: 44-1743-261-000
	Slough, Berkshire
	Wexham Park Hospital
		Contact Person	Ph: 44-1753-634-191
	South Shields
	South Tyneside District Hospital
		Contact Person	Ph: 44-1914-041-000
	Southampton
	Southampton General Hospital
		Christian Ottensmeier, MD, PhD	Ph: 44-23-8079-6184
			Email: cho@soton.ac.uk
	Stevenage
	Lister Hospital
		Contact Person	Ph: 44-1438-781-604
	Torquay
	Torbay Hospital
		Contact Person	Ph: 44-1803-656-620
	Walsall
	Walsall Manor Hospital
		Contact Person	Ph: 44-1922-721-172
	Weston-super-Mare
	Weston General Hospital
		Contact Person	Ph: 44-1934-881-135
	Wolverhampton
	New Cross Hospital
		Contact Person	Ph: 44-1902-307-999
	Worcester
	Worcestershire Royal Hospital
		Contact Person	Ph: 44-1905-733-194
	Worthing
	Worthing Hospital
		Contact Person	Ph: 44-1903-205-111
	Yeovil
	Yeovil District Hospital
		Contact Person	Ph: 44-1935-384-854
	York
	Cancer Care Centre at York Hospital
		Contact Person	Ph: 44-1904-726-488
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Contact Person	Ph: 44-1224-559-398
	Falkirk
	Falkirk and District Royal Infirmary
		Contact Person	Ph: 44-1324-566-316
Wales
	Cardiff
	Llandough Hospital
		Contact Person	Ph: 44-2920-615-888
	Velindre Cancer Center at Velindre Hospital
		Contact Person	Ph: 44-2920-615-888
	Gwent
	Nevill Hall Hospital
		Contact Person	Ph: 44-1633-238-536
	Haverfordwest
	Withybush General Hospital
		Contact Person	Ph: 44-1437-773-031
	Newport Gwent
	Royal Gwent Hospital
		Contact Person	Ph: 44-1633-234-266
	Rhyl, Denbighshire
	Glan Clwyd Hospital
		Contact Person	Ph: 44-1745-445-674
	Swansea
	Singleton Hospital
		Contact Person	Ph: 44-1792-285-547

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00433498
Information obtained from ClinicalTrials.gov on December 26, 2011

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