LungStar

1
LungStar
A MULTICENTRE PHASE III RANDOMISED DOUBLE BLIND
PLACEBO CONTROLLED TRIAL OF PRAVASTATIN ADDED TO
FIRST-LINE STANDARD CHEMOTHERAPY IN PATIENTS WITH
SMALL CELL LUNG CANCER
RATIONALE To see if the addition of
pravastatin to standard combination chemotherapy
(cisplatin and etoposide or carboplatin and
etoposide) improves
response rates, time to disease progression, and
survival in patients with SCLC
STUDY DESIGN
PRIMARY OBJECTIVE
ELIGIBILITY CRITERIA - Summarised

• Survival

Patients with histological or cytological
confirmed small cell lung cancer

• Histologically or cytologically confirmed SCLC
• Limited or extensive disease
• Performance status ECOG 0-3 (Appendix 3)
• Life expectancy gt 8 weeks
• Age 18 or over
• Willing and able to give informed consent
• Patient considered able to tolerate chemotherapy
• GFR gt 50mls/min by EDTA, OR gt 40 mls/min if by C
  G
• ANC gt1.5 x109/l Hb gt10.0g/dl plts gt100x109/l
• LFTs lt 3 x ULN
• Creatinine Kinase ? 5 X ULN
• No treatment with any statin within previous 12
  months
• No family history of hypercholesteroaemia
• No evidence of significant medical condition or
  lab
• finding making it undesirable for the patient
  to enter trial
• No treatment with fibrates e.g. bezofibrate,
  within 4 weeks
• prior to randomisation
• No patients on ciclosporin
• No symptomatic brain metastases requiring
  immediate

SECONDARY OBJECTIVES

• To compare treatments in terms of
• Progression-free survival
• Local progression-free survival
• Response rates
• Toxicity

All patients receive standard chemotherapy Cispla
tin/Etoposide or Carboplatin/Etoposide
Randomise prior to or within 1 working day of
starting chemotherapy
BIOLOGICAL STUDY

• All patients will have diagnostic tissue (where
  available), blood and urine samples studied or
  genetic and other markers which may predict for
  outcome and/or response to chemotherapy. Blood
  samples will be collected to assess biochemical
  markers of response to treatment, toxicity of
  treatment and survival in a subset of patients.
  
• Blood and urine samples should be collected at
  baseline pre cycle 4 at the 1st follow-up
  after the last chemotherapy cycle and at the
  end of treatment with pravastatin/placebo or at
  relapse/progression

Pravastatin daily for 2 years
Placebo daily for 2 years
Assessments with each cycle of chemotherapy
then, Follow up post chemotherapy, 2 monthly to 1
year from randomisation then 3 monthly thereafter
SAMPLE SIZE - 1300 patients
CONTACT DETAILS Lindsay James l.james_at_ctc.ucl.ac.
uk
Cancer Research UK UCL Cancer Trials Centre