Study Stopped
Low recruitment, lack of efficacy and increased adverse events in investigational arm.
STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
1 other identifier
interventional
72
1 country
13
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2017
Typical duration for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 30, 2016
CompletedStudy Start
First participant enrolled
March 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2021
CompletedMarch 18, 2021
March 1, 2021
4 years
March 8, 2016
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival
Defined as the time from randomisation to first progression/death (whichever came first), assessed up to 41 months
Secondary Outcomes (8)
Overall survival
From date of randomisation to death due to any cause, assessed up to 41 months
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
Adverse events
From date of consent to 30 days after final trial treatment
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
- +3 more secondary outcomes
Study Arms (2)
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
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
The Princess Alexandra Hospital NHS Trust
Harlow, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, United Kingdom
University Hospital Leicester NHS Trust
Leicester, United Kingdom
Guy's and St Thomas' Hospitals NHS Foundation Trust
London, United Kingdom
UCLH
London, United Kingdom
The Christie
Manchester, United Kingdom
East and North Herts NHS Foundation Trust
Northwood, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
North West Anglia NHS Trust
Peterborough, United Kingdom
Betsi Cadwaladr University Health Board
Rhyl, United Kingdom
Airedale NHS Foundation Trust
Steeton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2016
First Posted
March 30, 2016
Study Start
March 14, 2017
Primary Completion
March 12, 2021
Study Completion
March 12, 2021
Last Updated
March 18, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
On receipt of a request the recipient will consider the proposal, ensure relevant Chief Investigator/Trial Management Group are consulted and, if necessary, Trial Steering Committee and/or Cancer Trials Centre (CTC) Senior Management Group. Any shared data will be in an anonymised format