NCT02722369终止2 期
A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 13
- 主要终点
- Progression free survival
研究概览
简要总结
To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ) is associated with an improved clinical outcome (progression free and overall survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC)
详细描述
This is a multicentre, randomised, phase II trial which aims to compare the combination of hydroxychloroquine and gemcitabine/carboplatin versus standard carboplatin/etoposide chemotherapy, as first line treat in patients with stage IV disease.
The standard first line chemotherapy treatment remains a platinum-based chemotherapy and this has been unchanged for 20 years. Novel active treatment approaches are urgently needed to improve survival in SCLC.
Patients are randomised to one of two treatment arms; carboplatin/etoposide or gemcitabine/carboplatin/hydroxychloroquine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed SCLC
- •Stage IV disease
- •Performance status ECOG 0-2
- •Life expectancy >8 weeks
- •Age 18 or over
- •Willing and able to give informed consent
- •Patient considered able to tolerate chemotherapy
- •Adequate renal function - defined by GFR ≥50mL/min as measured by EDTA or C&G
- •Adequate bone marrow reserve: Absolute neutrophil count ≥1.5 x 109/L, haemoglobin ≥90 g/L, platelet count ≥100 x 109/L
- •Negative pregnancy test for WCBP
- •Highly effective contraception is mandatory for all patients of reproductive potential
- •At least one site of measurable disease (target lesion) for RECIST 1.1 evaluation
- •Hypersensitivity or history of severe allergic reaction to any of the IMPs
- •Able to swallow medication
排除标准
- •Mixed cell histology (i.e. NSCLC and SCLC)
- •Prior macular degeneration or diabetic retinopathy
- •History of glaucoma
- •Patients with abnormal LFTs (ALP, ALT/AST*) that are ≥3 x ULN (≥5 x ULN for patients with liver metastases)
- •Patients with abnormal bilirubin levels that are ≥1.5 x ULN
- •Prior treatment for this disease e.g. chemotherapy, surgery, radiotherapy (except palliative radiotherapy to bone metastases)
- •Documented side effects to chloroquine or related agents
- •Treatment with chloroquine or related agents within the last year prior to randomisation
- •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
- •Previous medical history of prolonged QT interval
- •A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
- •Patients with symptomatic brain metastases
- •Women who are breastfeeding
- •Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs e.g. phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine
- •Patients who are unable to have their digoxin levels regularly monitored
- •if both ALT and AST performed then both need to be recorded
研究组 & 干预措施
Control Arm
Active Comparator
- IV carboplatin AUC5 (area under curve) on Day1
- IV etoposide 120mg/m2 Day 1, followed by oral etoposide 100mg BD (twice daily) on Day 2 and Day 3
干预措施: Carboplatin (Drug)
Control Arm
Active Comparator
- IV carboplatin AUC5 (area under curve) on Day1
- IV etoposide 120mg/m2 Day 1, followed by oral etoposide 100mg BD (twice daily) on Day 2 and Day 3
干预措施: Etoposide (Drug)
Investigational Arm
Experimental
- IV gemcitabine 1200mg/m2 on Day 1 and Day 8
- IV carboplatin AUC5 on Day 1
- Oral HCQ will be taken at a dose of 400mg BD from day 1 of cycle 1 (maximum of 30 months)
干预措施: Gemcitabine (Drug)
Investigational Arm
Experimental
- IV gemcitabine 1200mg/m2 on Day 1 and Day 8
- IV carboplatin AUC5 on Day 1
- Oral HCQ will be taken at a dose of 400mg BD from day 1 of cycle 1 (maximum of 30 months)
干预措施: Carboplatin (Drug)
Investigational Arm
Experimental
- IV gemcitabine 1200mg/m2 on Day 1 and Day 8
- IV carboplatin AUC5 on Day 1
- Oral HCQ will be taken at a dose of 400mg BD from day 1 of cycle 1 (maximum of 30 months)
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Progression free survival
时间窗: Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months
次要结局
- Overall survival(From date of randomisation to death due to any cause, assessed up to 41 months)
- Quality of life as measured by QLQ-LC-13(From baseline to progression/trial end (whicenver is first), assessed up to 41 months)
- Compliance measured by dose intensity(From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months)
- Quality of life as measured by EQ-5D(From baseline to progression/trial end (whichever is first), assessed up to 41 months)
- Quality of life as measured by QLQC-30(From baseline to progression/trial end (whichever is first), assessed up to 41 months)
- Adverse events(From date of consent to 30 days after final trial treatment)
- Objective response as measured by Response Evaluation Criteria in Solid Tumours (RECIST) v.1.1(From first tumour assessment to progression/trial end (whichever is first), assessed up to 41 months)
- Compliance measured by dose exposure(From first date of trial treatment to progression/trial end (whichever is first), assessed up to 41 months)
研究者
研究点 (13)
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