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)
- Conditions
- Stage 3B that is unsuitable for chemoradiation and stage 4 non-small cell lung cancerCancerNon-small cell lung cancer (NSCLC)
- Registration Number
- ISRCTN45605573
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1270
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 1. Progression-free survival<br>2. Response rates and clinical benefit<br>3. Toxicity<br>4. Symptom control and quality of life