Last updated on May 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Small Cell Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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