Overview

STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)

Status:
Terminated
Trial end date:
2021-03-12
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University College, London
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
Gemcitabine
Hydroxychloroquine
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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