Lung CancerPhase 3NCT00433498
Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung Cancer
A Phase 3 study testing carboplatin, cisplatin and etoposide phosphate in people with Lung Cancer, run by University College, London at 86 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, cisplatin and etoposide phosphate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 846 participants
- Where
- 86 sitesUnited Kingdom
- Study dates
- Jan 2007to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
86 sites in 1 country.
86 sites in 1 country
United Kingdom86 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
William Harvey Hospital
Ashford-Kent, England, TN24 0LZ
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, HP21 8AL
North Devon District Hospital
Barnstaple, England, EX31 4JB
Royal United Hospital
Bath, England, BA1 3NG
City Hospital - Birmingham
Birmingham, England, B18 7QH
Sandwell General Hospital
Birmingham, England, B71 4HJ
Good Hope Hospital
Birmingham, England, B75 7RR
Birmingham Heartlands Hospital
Birmingham, England, B9 5SS
Royal Bournemouth Hospital
Bournemouth, England, BH7 7DW
Bradford Royal Infirmary
Bradford, England, BD9 6RJ
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, BN2 5BE
Queen's Hospital
Burton-on-Trent, England, DE13 0RB
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, CT1 3NG
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Llandough Hospital
Cardiff, Wales, CF64 2XX
Broomfield Hospital
Chelmsford, England, CM1 7ET
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Essex County Hospital
Colchester, England, C03 3NB
Queen Alexandra Hospital
Cosham, England, PO6 3LY
Darent Valley Hospital
Dartford Kent, England, DA2 8DA
Royal Derby Hospital
Derby, England, DE22 3NE
Dorset County Hospital
Dorchester, England, DT1 2JY
University Hospital of North Durham
Durham, England, DH1 5TW
Princess Alexandra Hospital
Essex, England, CM20 1QX
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
Falkirk and District Royal Infirmary
Falkirk, Scotland, FK1 5QE
Gloucestershire Royal Hospital
Gloucester, England, GL1 3NN
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Nevill Hall Hospital
Gwent, Wales
Harrogate District Hospital
Harrogate, England, HG2 7SX
Withybush General Hospital
Haverfordwest, Wales, SA61 2PZ
Hereford Hospitals
Hereford, England, HR1 2ER
Wycombe General Hospital
High Wycombe, England
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Castle Hill Hospital
Hull, England, HU16 5JQ
Ipswich Hospital
Ipswich, England, IP4 5PD
Airedale General Hospital
Keighley, England, BD20 6TD
Queen Elizabeth Hospital
Kings Lynn, England, PE30 4ET
Cancer Research UK Clinical Centre at St. James's University Hospital
Leeds, England, LS16 6QB
Leicester Royal Infirmary
Leicester, England, LE1 5WW
University College Hospital
London, England, NW1 2BU
Guy's Hospital
London, England, SE1 9RT
Queen Elizabeth Hospital - Woolwich
London, England, SE18 4QH
St. George's Hospital
London, England, SW17 0QT
Charing Cross Hospital
London, England, W6 8RF
Luton and Dunstable Hospital
Luton, England, LU4 0DZ
Maidstone Hospital
Maidstone, England, ME16 9QQ
Christie Hospital
Manchester, England, M20 4BX
Wythenshawe Hospital
Manchester, England, M23 9LJ
Queen Elizabeth The Queen Mother Hospital
Margate, England, CT9 4AN
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Milton Keynes General Hospital
Milton Keynes, England, MK6 5LD
Freeman Hospital
Newcastle upon Tyne, England, NE7 7DN
St. Mary's Hospital
Newport, England, PO30 5TG
Royal Gwent Hospital
Newport Gwent, Wales, NP9 2UB
Friarage Hospital
North Yorks, England, DL6 1JG
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Northampton General Hospital
Nottingham, England, NG5 1PB
Nottingham City Hospital
Nottingham, England, NG5 1PB
King's Mills Hospital
Nottinghamshire, England, NG17 4JL
Princess Royal University Hospital
Orpington, Kent, England, BR6 8ND
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Derriford Hospital
Plymouth, England, PL6 8DH
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, RG1 5AN
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Salisbury District Hospital
Salisbury, England, SP2 8BJ
Scarborough General Hospital
Scarborough, England, YO12 6QL
Scunthorpe General Hospital
Scunthorpe, England, DN15 7BH
Royal Shrewsbury Hospital
Shrewsbury, England, SY3 8XQ
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
South Tyneside District Hospital
South Shields, England, NE34 0PL
Southampton General Hospital
Southampton, England, SO16 6YD
Lister Hospital
Stevenage, England, SG1 4AB
Singleton Hospital
Swansea, Wales, SA2 8QA
Torbay Hospital
Torquay, England, TQ2 7AA
Walsall Manor Hospital
Walsall, England, WS2 9PS
Weston General Hospital
Weston-super-Mare, England, BS23 4TQ
New Cross Hospital
Wolverhampton, England, WV10 0QP
Worcestershire Royal Hospital
Worcester, England, WR5 1AN
Worthing Hospital
Worthing, England, BN11 2DH
Yeovil District Hospital
Yeovil, England, BA21 4AT
Cancer Care Centre at York Hospital
York, England, Y031 8HE
About this study
Official title: A Multicentre Phase III Randomized Double Blind Placebo Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Patients With Small Lung Cancer
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, cisplatin, etoposide phosphate, pravastatin sodium
- Keywords
- extensive stage small cell lung cancer, limited stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
cisplatinDrug
Should be given according to local practice but suggested doses and schedules are provided in the protocol.
etoposide phosphateDrug
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 sodiumDrug
40mg daily oral tablet taken for a maximum of 2 years
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin/cisplatin and Etoposide with Pravastatin | Experimental | Not described Receives: Drug: carboplatin; Drug: cisplatin; Drug: etoposide phosphate; Drug: pravastatin sodium |
| Carboplatin/cisplatin and Etoposide with Placebo | Placebo comparator | Not described Receives: Drug: carboplatin; Drug: cisplatin; Drug: etoposide phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Reported at death.
Secondary outcomes (4)
Progression-free survival
Measured: Time until the date of disease progression
Local progression-free survival (local control)
Measured: Time until the date of disease progression
Response rate as measured by RECIST criteria after course 3
Measured: Post chemo cycle 3
Toxicity as measured by CTCAE version 3.0
Measured: At every clinic visit or if serious, an SAE form shoudl be submitted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J. Seckl, MD, PhD, Study chair, Charing Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433498
- Sponsor's protocol ID
- CDR0000531141
- Other IDs
- CRUK-LUNGSTAR, EU-20649, ISRCTN56306957, EUDRACT-2005-005821-71, UCL-BRD/05/129, MREC-06-MRE10-28, CTA-20363-0215-001, CTAAC-C1312-A5335
- Status last verified
- Jan 2013
- First submitted
- 8 Feb 2007
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase III Randomized Double Blind Placebo Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Patients With Small Lung Cancer
- ClinicalTrials.gov ID
- NCT00433498
- Acronym / sponsor ID
- CDR0000531141
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer, limited stage small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatinShould be given according to local practice but suggested doses and schedules are provided in the protocol. | Drug | Carboplatin/cisplatin and Etoposide with Placebo, Carboplatin/cisplatin and Etoposide with Pravastatin |
| cisplatinShould be given according to local practice but suggested doses and schedules are provided in the protocol. | Drug | Carboplatin/cisplatin and Etoposide with Placebo, Carboplatin/cisplatin and Etoposide with Pravastatin |
| etoposide phosphateDay 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. | Drug | Carboplatin/cisplatin and Etoposide with Placebo, Carboplatin/cisplatin and Etoposide with Pravastatin |
| pravastatin sodium40mg daily oral tablet taken for a maximum of 2 years | Drug | Carboplatin/cisplatin and Etoposide with Pravastatin |
Primary outcome
Survival
Time frame: Reported at death.
4 secondary outcomes
Progression-free survival
Time frame: Time until the date of disease progression
Local progression-free survival (local control)
Time frame: Time until the date of disease progression
Response rate as measured by RECIST criteria after course 3
Time frame: Post chemo cycle 3
Toxicity as measured by CTCAE version 3.0
Time frame: At every clinic visit or if serious, an SAE form shoudl be submitted
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J. Seckl, MD, PhD study chair
Charing Cross Hospital
86 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboplatin, cisplatin and etoposide phosphate in people with Lung Cancer, run by University College, London at 86 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Reported at death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.