Condition category
Cancer
Date applied
07/02/2006
Date assigned
17/02/2006
Last edited
21/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Seckl

ORCID ID

Contact details

Department of Medical Oncology
Charing Cross Hospital
Fulham Palace Road
Hammersmith
London
W6 8RF
United Kingdom
+44 (0)20 8846 1421
m.seckl@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Lungstar 2

Study hypothesis

To determine if survival is affected by the addition of pravastatin to docetaxel and cisplatin/carboplatin chemotherapy in patients with non-small cell lung cancer (NSCLC).

Ethics approval

Approval pending

Study design

Double-blind placebo-controlled multicentre phase III study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stage 3B that is unsuitable for chemoradiation and stage 4 non-small cell lung cancer

Intervention

Patients will receive chemotherapy with docetaxel and either carboplatin or cisplatin. They will be randomised to either pravastatin or placebo. Chemotherapy will last for four cycles unless there is evidence of progression or occurrence of unacceptable toxicities. Oral pravastatin or placebo will commence on day 1 of the first chemotherapy cycle.

Study entrants will be required to undergo all standard staging investigations. They will be required to provide a pre-chemotherapy full blood count as well as urea, creatinine and liver function tests before each cycle of chemotherapy. A staging computerised tomography (CT) scan will be performed mid-treatment (post cycle 2) and at the end of chemotherapy. A separate consent will be obtained for the collection of additional blood samples and tissue for translational research. A quality of life and toxicity questionnaire will be required at each visit.

Intervention type

Drug

Phase

Phase III

Drug names

Pravastatin, docetaxel, cisplatin, carboplatin

Primary outcome measures

To determine if survival is affected by the addition of pravastatin to docetaxel and cisplatin/carboplatin chemotherapy in patients with non-small cell lung cancer.

Secondary outcome measures

1. Progression-free survival
2. Response rates and clinical benefit
3. Toxicity
4. Symptom control and quality of life

Overall trial start date

01/06/2006

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological or cytological-confirmed NSCLC
2. Stage IV disease or stage IIIB disease that is unsuitable for radio-chemotherapy
3. Presence of one or more measurable lesions (by Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
4. Estimated life expectancy of at least 12 weeks
5. Performance status 0, 1 or 2
6. Aged 18 or over
7. Patients must be able to give informed consent
8. Adequate haematological function (absolute neutrophil count [ANC] greater than 1.5 x 10^9 /l, platelets greater than 100 x 10^9 /l, and haemoglobin greater than 9 g/dl)
9. Adequate renal function: ethylenediaminetetraacetic acid (EDTA) based glomerular filtration rate of greater than 55 ml/min or a 24-hour creatinine clearance of greater than 60 ml/min
10. Adequate hepatobiliary function: serum bilirubin less than 1.5 times the upper limit of normal (ULN) and serum aspartate aminotransferase (AST) and/or alanine transaminase (ALT) less than 2.5 x ULN in patients without liver involvement or less than 5.0 x ULN in patients with liver metastases
11. Patient compliance and geographic proximity allowing for adequate follow-up
12. Female patients potentially able to bear children should use an approved contraceptive method (intrauterine device [IUD], birth control pills or barrier device) during and for three months after the study. All male patients should take adequate contraceptive precautions during and up to two months after the study
13. Written informed consent prior to admission to this study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1270

Participant exclusion criteria

1. Presence of central nervous system metastases
2. Prior chemotherapy or radiotherapy for this disease
3. Protocol chemotherapy should start after randomisation (except for example when a patient needs to start chemotherapy urgently, randomisation may occur at a maximum of one working day after day 1 of cycle 1 but consent to the trial must always be obtained prior to starting chemotherapy)
4. Creatinine kinase greater than or equal to 5 x ULN
5. Patients treated with statins (e.g. simvastatin, pravastatin, atorvastatin) within one year prior to randomisation
6. Patients treated with fibrates (e.g. bezofibrate, gemfibrozil, fenofibrate) within four weeks prior to randomisation
7. Patients on cyclosporine
8. Hypersensitivity to docetaxel, carboplatin, cisplatin or pravastatin or any of their excipients
9. Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
10. Evidence of uncontrolled infection
11. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
12. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years or the tumour was a non-melanoma skin tumour or early cervical cancer
13. Pregnancy and lactation; effective contraception is mandatory for all patients of reproductive potential if sexually active whilst in the study. Contraception should continue for one year post completion of all chemotherapy or radiotherapy and a further 28 days after cessation of pravastatin/placebo

Recruitment start date

01/06/2006

Recruitment end date

01/06/2011

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Department of Medical Oncology
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Hammersmith Campus
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 5828
c.coombes@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Industry

Funder name

Sanofi-Aventis (UK) - supplied a grant of £350,000 for investigator-led study

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Clinical Trials Advisory and Awards Committee (CTAAC) (UK) - application pending for additional funding for the translational research aspect of the study

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes