A multicentre, phase III, randomised, double-blind, placebo-controlled trial of pravastatin added to first-line chemotherapy in patients with small cell lung cancer

niversity College London (UK)0 个研究点目标入组 860 人开始时间: 2006年5月8日最近更新: 2022年11月7日

研究概览

•1. Histologically or cytologically confirmed SCLC
•2. Limited or extensive disease
•3. Performance status Eastern Cooperative Oncology Group (ECOG) zero to three
•4. Life expectancy more than 8 weeks
•5. Age 18 or over
•6. Willing and able to give informed consent
•7. Patient considered able to tolerate chemotherapy
•8. Adequate renal function - defined by glomerular filtration rate (GFR) more than 50 ml/min if measured by EthyleneDiamineTetraacetic Acid (EDTA) or GFR more than 40 ml/min if measured by the Cockcroft and Gault (C & G) formula. Cisplatin and etoposide dose should be modified according to renal function as per dose modification schedule.
•9. Adequate bone marrow reserve - Absolute Neutrophil Count (ANC) more than 1.5 x 10^9 /l, Haemoglobin (Hb) more than 10.0 g/dl and platelet count more than 100 x 10^9 /l
•10. Liver function tests less than three times Upper Limit of Normal (ULN)
•11. Creatine Kinase less than or equal to five times ULN

•1. Prior chemotherapy for this disease (protocol chemotherapy should start after randomisation except for where a patient needs to start chemotherapy urgently, randomisation may occur a maximum of one working day after day one of cycle one)
•2. Prior radiotherapy for this disease (except for prior radiotherapy to distant metastases i.e. not within the thorax or thoracic or cervical spine is acceptable)
•3. 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
•4. Patients with a family history of hypercholesterolaemia
•5. 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
•6. Patients treated with fibrates e.g. bezofibrate, gemfibrozil, fenofibrate within four weeks prior to randomisation
•7. Patients on cyclosporin
•8. Patients with symptomatic brain metastases, which require immediate radiotherapy
•9. 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 or placebo
•10. Treatment with any statin within previous 12 months

发起方

niversity College London (UK)