A randomised controlled phase II trial of oral vinorelbine as second line therapy for patients with malignant pleural mesothelioma - VIM

niversity of Leicester0 个研究点目标入组 200 人开始时间: 2015年3月10日最近更新: 2015年9月7日

试验速览

暂无简介。

•1.Confirmed histological diagnosis of malignant pleural mesothelioma. The same block or 10 unstained slides should be available for translational research
•2.Prior treatment with first-line standard platinum doublet based chemotherapy only
•3.Evidence of disease progression according to CT scan
•4.Life expectancy = 3 months
•5.ECOG performance status 0-2
•6.Men or women aged 18 years or over
•7.Willing to consent to provide blood and tissue for translational research
•8.Disease which is measurable using modified RECIST.
•9.Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil count (ANC) = 1.5 x 109/L, WBC >3 x 109/L, haemoglobin = 100g/L, platelets = 100 x 109/L; adequate liver function: Bilirubin <1.5 x ULN AST/ALT 1.5- 2.5 x ULN.
•10.Patients with reproductive potential (male or female), who are sexually active during the duration of the trial or the drug washout period, should be prepared to use two effective forms of contraception throughout their participation in the trial and for at least three months after the last dose of vinorelbine.
•11.Patients must provide informed consent before any study specific procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1.Patients with a diagnosis of a second malignancy except prostate or cervical cancer in remission or patients with a diagnosis of basal cell carcinoma of the skin.
•2.Have received treatment with an agent that has no marketing authorisation, within 30 days of study entry.
•3.Are pregnant or breastfeeding. If a participant becomes pregnant during the trial, and is randomised to the treatment arm, vinorelbine must be discontinued and the participant followed up until birth or termination of pregnancy. Breastfeeding must be avoided as it is unknown whether vinorelbine is excreted in human milk.
•4.Uncontrolled CNS disease.
•5.Known contraindication or hypersensitivity to vinorelbine or other vinca alkaloids or to any of the constituents
•6.Any disease significantly affecting absorption
•7.Previous significant surgical resection of stomach or small bowel
•8.Yellow fever vaccine within 30 days of consent
•9.Previous vinca alkaloid chemotherapy
•10.Palliative radiotherapy within the RECIST area in the 4 weeks prior to baseline CT chest up until randomisation.
•11.Patients that are unable to swallow

发起方

niversity of Leicester