non-small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB MedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Trade Name: Lipostat
Product Name: Pravastatin
Pharmaceutical Form: Tablet
Sponsors
Imperial College, London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Stage IIIB disease that is unsuitable to radio-chemotherapy or Stage IV disease. •Estimated life expectancy of at least 12 weeks. •ECOG Performance status 0, 1 or 2 •Aged 18 or over. •Patient able to give informed consent •Adequate haematologic function (ANC greater than 1.5x109/L, platelets greater than 100x109/L, and haemoglobin greated than 9 g/dl). •Adequate renal function: EDTA-based or calculated (using the Wright formula; see appendix 3 or the Cockcroft-Gault formula) glomelular filtration rate of > 55 mL/min •Adequate hepato-biliary function: Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Symptomatic Central Nervous System (CNS) involvement. •Prior treatment with more than one chemotherapy regimen •Patient has received a statin within 2 weeks prior to registration •Creatine Kinase > 5xULN •Concomitant use of -CYP3A4 inhibitors such as cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, or large quantities of grapefruit juice (>250 mL/d) - Lipid-lowering drugs that can cause myopathy such as gemfibrozil, other fibrates, or lipid-lowering doses (>1 g/day) of niacin •Hypersensitivity to docetaxel, cisplatin or pravastatin or any of their excipients. •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 •Evidence of uncontrolled infection. •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. •Pregnancy and lactation. Effective contraception (IUD, birth control pills or barrier device) is mandatory for all patients of reproductive potential if sexually active whilst in the study. Contraception should continue for 1 year post completion of all chemotherapy/radiotherapy and a further 28 days after cessation of pravastatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetics of docetaxel and cisplatin in patients with advanced or metastatic non-small cell lung cancer (NSCLC) treated with pravastatin, docetaxel and cisplatin, and to estimate the PK interaction between pravastatin, docetaxel and cisplatin.;Secondary Objective: To establish the safety and tolerability of pravastatin when co-administered with docetaxel and cisplatin in patients with advanced or metastatin nsclc. To make a preliminary assessment of the efficacy of docetaxel and cisplatin when co-administered with pravastatin in patients with advanced or metastatic nsclc.;Primary end point(s): Assess the pharmacokinetics of docetaxel and cisplatin in patients with advanced or metastatic nsclc treated with pravastatin, docetaxel and cisplatin, and to estimate the PK interaction between pravastatin, docetaxel and cisplatin. | — |
Countries
United Kingdom
Outcome results
None listed