Randomized Phase III Trial to evaluate the effect of statins on tumour biology in non-small cell lung cancer. - Neostat

• Conditions: on-small cell lung cancer; MedDRA version: 9.1Level: LLTClassification code 10025050Term: Lung cancer non-small cell stage I; MedDRA version: 9.1Level: LLTClassification code 10025051Term: Lung cancer non-small cell stage II; MedDRA version: 9.1Level: LLTClassification code 10025052Term: Lung cancer non-small cell stage III; MedDRA version: 9.1Level: LLTClassification code 10025053Term: Lung cancer non-small cell stage IIIA

• Registration Number: EUCTR2007-000903-14-GB
• Lead Sponsor: Imperial College, London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Histological or cytological confirmed NSCLC or sufficiently strong clinical evidence to justify thoracotomy.
Stage I-IIIA disease that is suitable for surgical resection.
Surgery planned between 14 and 42 days after registration.
Serum Creatinine concentration <1.5 times the upper limit of normal. (ULN)
Aged 18 or over.
Written informed consent prior to admission to this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior chemotherapy or radiotherapy for this disease.
Patients treated with statins within 1 year prior to randomization.
Active liver disease or unexplained elevation of AST and/or ALT >2.5xULN.
Creatinine Kinase >5xULN.
Concomitant use of: CYPA4 inhibitors such as cyclosporine, itraconazole, ketoconazole, erythroymicin, clarithromycin,HIV protease inhibitors, jefazodone, or larg quantities of grapefruit juice (>250ml/day)
Lipid-lowering drugs that can cause myopathy such as gemifibrozil, other fibrates, or lipid-lowering doses (>1g/day) of niacin.
Amiodarone or verapamil.
Hypersensitivity to lovastatin or pravastatin or any of their excipients.
Evidence of significant mediacal condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial.
Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate and compare changes in tumour cell proliferation measured through tumour Ki-67 expression following treatment with pravastatin or lovastatin.;Secondary Objective: The secondary objective is to evaluate and compare other biological changes in the tumour following pravastatin or lovastatin treatment and then to identify potential surrogate parameters for anti-tumour effects of statins.;Primary end point(s): The primary objective is to evaluate treatment-induced changes in tumour cell proliferation measured through tumour Ki-67 expression. The primary efficacy endpoint of the trial is the percentage of patients with high tumour Ki-67 expression at the end of treatment with pravastatin or lovastatin. Ki67 expression will primarily be compared between the surgical samples of the treatment groups and the control group.