Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer

NCT00433498 | Completed Phase 3 DMC

• 10 other identifiers: CDR0000531141CRUK-LUNGSTAREU-20649ISRCTN56306957EUDRACT-2005-005821-71UCL-BRD/05/129MREC-06-MRE10-28CTA-20363-0215-001CTAAC-C1312-A5335CTAAC-C1312-A12462
• Study Type: interventional
• Target: 846
• Locations: 1 country
• Sites: 86

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Survival

  Reported at death.

Secondary Outcomes (4)

• Progression-free survival

  Time until the date of disease progression

• Local progression-free survival (local control)

  Time until the date of disease progression

• Response rate as measured by RECIST criteria after course 3

  Post chemo cycle 3

• Toxicity as measured by CTCAE version 3.0

  At every clinic visit or if serious, an SAE form shoudl be submitted

Study Arms (2)

Carboplatin/cisplatin and Etoposide with Pravastatin

EXPERIMENTAL

Drug: carboplatin; Drug: cisplatin; Drug: etoposide phosphate; Drug: pravastatin sodium

Carboplatin/cisplatin and Etoposide with Placebo

PLACEBO COMPARATOR

Drug: carboplatin; Drug: cisplatin; Drug: etoposide phosphate

Interventions

carboplatin DRUG

Should be given according to local practice but suggested doses and schedules are provided in the protocol.

Carboplatin/cisplatin and Etoposide with Placebo; Carboplatin/cisplatin and Etoposide with Pravastatin

cisplatin DRUG

Should be given according to local practice but suggested doses and schedules are provided in the protocol.

Carboplatin/cisplatin and Etoposide with Placebo; Carboplatin/cisplatin and Etoposide with Pravastatin

etoposide phosphate DRUG

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.

Carboplatin/cisplatin and Etoposide with Placebo; Carboplatin/cisplatin and Etoposide with Pravastatin

pravastatin sodium DRUG

40mg daily oral tablet taken for a maximum of 2 years

Carboplatin/cisplatin and Etoposide with Pravastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead

Study Sites (86)

William Harvey Hospital

Ashford-Kent, England, TN24 0LZ, United Kingdom

Location

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Sandwell General Hospital

Birmingham, England, B71 4HJ, United Kingdom

Location

Good Hope Hospital

Birmingham, England, B75 7RR, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Bradford Royal Infirmary

Bradford, England, BD9 6RJ, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

Broomfield Hospital

Chelmsford, England, CM1 7ET, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Queen Alexandra Hospital

Cosham, England, PO6 3LY, United Kingdom

Location

Darent Valley Hospital

Dartford Kent, England, DA2 8DA, United Kingdom

Location

Royal Derby Hospital

Derby, England, DE22 3NE, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

University Hospital of North Durham

Durham, England, DH1 5TW, United Kingdom

Location

Princess Alexandra Hospital

Essex, England, CM20 1QX, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Harrogate District Hospital

Harrogate, England, HG2 7SX, United Kingdom

Location

Hereford Hospitals

Hereford, England, HR1 2ER, United Kingdom

Location

Wycombe General Hospital

High Wycombe, England, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Castle Hill Hospital

Hull, England, HU16 5JQ, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Airedale General Hospital

Keighley, England, BD20 6TD, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, England, PE30 4ET, United Kingdom

Location

Cancer Research UK Clinical Centre at St. James's University Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

University College Hospital

London, England, NW1 2BU, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

Queen Elizabeth Hospital - Woolwich

London, England, SE18 4QH, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Luton and Dunstable Hospital

Luton, England, LU4 0DZ, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Wythenshawe Hospital

Manchester, England, M23 9LJ, United Kingdom

Location

Queen Elizabeth The Queen Mother Hospital

Margate, England, CT9 4AN, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Milton Keynes General Hospital

Milton Keynes, England, MK6 5LD, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

St. Mary's Hospital

Newport, England, PO30 5TG, United Kingdom

Location

Friarage Hospital

North Yorks, England, DL6 1JG, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Northampton General Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

King's Mills Hospital

Nottinghamshire, England, NG17 4JL, United Kingdom

Location

Princess Royal University Hospital

Orpington, Kent, England, BR6 8ND, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

South Tyneside District Hospital

South Shields, England, NE34 0PL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Lister Hospital

Stevenage, England, SG1 4AB, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Worcestershire Royal Hospital

Worcester, England, WR5 1AN, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, Scotland, FK1 5QE, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Llandough Hospital

Cardiff, Wales, CF64 2XX, United Kingdom

Location

Nevill Hall Hospital

Gwent, Wales, United Kingdom

Location

Withybush General Hospital

Haverfordwest, Wales, SA61 2PZ, United Kingdom

Location

Royal Gwent Hospital

Newport Gwent, Wales, NP9 2UB, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Singleton Hospital

Swansea, Wales, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Carboplatin; Cisplatin; etoposide phosphate; Pravastatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Michael J. Seckl, MD, PhD

  Charing Cross Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 12, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: November 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2013-01

Locations

GB (86)