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)

Imperial College London0 sites1,270 target enrollmentFebruary 17, 2006

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Stage 3B that is unsuitable for chemoradiation and stage 4 non-small cell lung cancer
Sponsor: Imperial College London
Enrollment: 1270
Status: Completed
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

February 17, 2006

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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