ISRCTN44518069已完成2 期
A randomised controlled phase II trial of oral vinorelbine as second line therapy for patients with malignant pleural mesothelioma
niversity of Leicester0 个研究点目标入组 154 人开始时间: 2017年1月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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. Re-challenge with first line chemotherapy is allowed.
- •3. Evidence of disease progression according to CT scan on Modified RECIST
- •4. Life expectancy = 3 months
- •5. ECOG performance status 0-1
- •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. Effective forms of contraception would include condom with spermicide, along with one of the following: oral contraceptive or hormonal therapy (e.g. hormone implants); placement of an inter-uterine device; vasectomy with assurance of post- vasectomy confirmation of azoospermia; tubal occlusion. Accepted hormonal methods include: Etonogestrel implants; normal and low dose combined oral pills; orelgestromin/ethinyl estradiol transdermal system; or desogestrel.
- •11. Patients must provide informed consent before any study specific procedures
排除标准
- •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
研究者
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