A phase II, multicentre, randomised trial comparing combination gemcitabine/carboplatin and hydroxychloroquine versus carboplatin/etoposide therapy alone in small cell lung cancer (SCLC)
- Conditions
- Small cell lung cancerMedDRA version: 20.0Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004170-15-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 112
•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
•Able to swallow medication
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 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56
•Mixed cell histology (i.e. NSCLC and SCLC)
•Prior macular degeneration or diabetic retinopathy
•Patients with abnormal bilirubin levels that are =2 x ULN
•Prior treatment for this disease e.g. chemotherapy, surgery, radiotherapy (except palliative radiotherapy to bone metastases)
•Hypersensitivity or history or severe allergic reaction to any of the IMPs
•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 pregnant or 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
•Infection with blood borne viruses (BBVs) such as Hepatitis C, Hepatitis B and HIV
* if both ALT and AST performed then both need to be recorded and reviewed
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 compare the efficacy of hydroxychloroquine and gemcitabine/carboplatin with standard carboplatin/etoposide in SCLC patients in terms of progression free survival.;Secondary Objective: Secondary objectives are overall survival, responses rates (according to RECIST v1.1), compare adverse events between the two treatment arms, compare the quality of life of patients treated with hydroxychloroquine and gemcitabine/carboplatin with those treated with carboplatin/etoposide alone, and to assess treatment compliance between the two treatment arms.;Primary end point(s): The primary outcome measure is progression free survival measured from the time of randomisation to progression or death (whichever occurs first).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Overall survival (from date of randomisation to death due to any cause)<br>•Objective response (CR, PR, SD, PD) as assessed by RECIST v1.1<br>•Adverse Events (NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03)<br>•Quality of Life measured by QLQC-30, QLQ-LC-13 and EQ-5D<br>•Compliance (dose intensity and exposure)<br>