A multicentre phase III randomised double-blind placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with non-small cell lung cancer (LungStar 2 trial)
| ISRCTN | ISRCTN45605573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45605573 |
| Secondary identifying numbers | N/A |
- Submission date
- 07/02/2006
- Registration date
- 17/02/2006
- Last edited
- 13/04/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Michael Seckl
Scientific
Scientific
Department of Medical Oncology
Charing Cross Hospital
Fulham Palace Road
Hammersmith
London
W6 8RF
United Kingdom
| Phone | +44 (0)20 8846 1421 |
|---|---|
| m.seckl@imperial.ac.uk |
Study information
| Study design | Double-blind placebo-controlled multicentre phase III study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multicentre phase III randomised double-blind placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with non-small cell lung cancer (LungStar 2 trial) |
| Study acronym | Lungstar 2 |
| Study hypothesis | The aim of this study is 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Pravastatin, docetaxel, cisplatin, carboplatin |
| Primary outcome measure | 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 study start date | 01/06/2006 |
| Overall study end date | 01/06/2011 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1270 |
| 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 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
- England
- Ireland
- United Kingdom
Study participating centre
Department of Medical Oncology
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Imperial College London
University/education
University/education
Hammersmith Campus
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom
| Phone | +44 20 8383 5828 |
|---|---|
| c.coombes@imperial.ac.uk | |
| Website | http://www3.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Industry
Sanofi-Aventis
No information available
Clinical Trials Advisory and Awards Committee
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
13/04/2017: This study was stopped due to problems with recruitment.
