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