None listed
Conditions
Brief summary
The primary objective of the study is to estimate the benefit of adding cetuximab to standard chemotherapy, administered prior to surgery. Cetuximab inhibits the Epidermal Growth Factor receptor. Additional objectives are to examine the relationships between various measures of tumour shrinkage and various molecular analyses of normal and cancer tissues. This may provide information on how cetuximab works, and which patients benefit most from the drug, as well as further information on the effects of chemotherapy.
Interventions
Standard chemotherapy (cisplatin 75mg/m2 i.v. and docetaxel 75mg/m2 i.v., 3-weekly for 3 cycles) plus cetuximab 400mg/m2 i.v., then 250mg/m2 i.v. weekly, followed by surgery
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Histological diagnosis of NSCLC 2) Adequate baseline histological specimen available 3) Measurable primary tumour 4) Stage II or IIIA 5) Considered to be surgically resectable by thoracic surgeon 6) No prior therapy for NSCLC 7) Performance Status 0-1 8) Peripheral neuropathy no worse than grade I 9) Adequate organ function including lung, hepatic, renal and haematological function 10) Written informed consent
Exclusion criteria
1) No prior malignancy within 5 years 2) No other concurrent investigational drug 3) No active infection 4) No pregnancy or breast feeding 5) No serious concomitant medical or psychiatric disorders 6) No significant cardiovascular disease 7) No concurrent systemic corticosteroid (prednisolone >10 mg/day, or equivalent) 8) No history of severe hypersensitivity reactions to polysorbate 80 or any of the study medications.
Outcome results
None listed