Open-Label, Uncontrolled, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cetuximab in Combination With Cisplatin & Gemcitabine as First-Line Therapy in Patients With Advanced Non Small Cell Lung Cancer
Criteria for inclusion Signed written informed consent Male or female ≥18 years of age
Cito-histological diagnosis of NSCLC, stage IV Performance Status = 0 or 1 Measurable
disease on CT scan - RECIST criteria White blood count ≥ 3 x 109/L, Neutrophils ≥ 1.5 x
109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL Bilirubin level either normal or
≤1.5 x ULN ASAT and ALAT ≤ 2.5 x ULN (or 5 x ULN in case of liver metastases) Alkaline
phosphatase ≤ 2,5 x ULN or ≤ 5 x ULN in case of bone metastases Creatinine clearance ≥ 50
ml/min Negative pregnancy test within one week before treatment start, if applicable Life
expectancy of ≥ 3 months Availability of tumor sample (or able and willing to provide tumor
sample) for EGFR assessment Effective contraception for both male and female patients if the
risk of conception exists Criteria for exclusion Documented or symptomatic brain metastases
Previous chemotherapy for NSCLC including adjuvant chemotherapy Concurrent chronic systemic
immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any
investigational agent(s) within 4 weeks prior to entry Major surgery within 4 weeks prior to
study entry Prior chest irradiation within 12 weeks prior to study entry (palliative
radiation of bone lesions is allowed) Superior vena cava syndrome contra-indicating
hydratation Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors
or EGFR targeting therapy Myocardial infraction within 6 months prior to study entry,
uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder
despite treatment Known allergic / hypersensitivity reaction to any of the components of
study treatments Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity
Symptomatic peripheral neuropathy (NCI-CTC) ≥ 2 and/or ototoxicity grade ≥ 2 , except if due
to trauma or mechanical impairment due to tumor mass Medical or psychological condition
which in the opinion of the investigator would not permit the patient to complete the study
or sign meaningful informed consent Pregnancy or breastfeeding Any previous or concurrent
malignancy other than nonmelanoma skin cancer, or carcinoma in situ of the cervix. (Patients
with a previous malignancy but without evidence of disease for > 5 years will be allowed to
enter the trial)
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
oVERALL RESPONSE RATE
30/11/2009
Fernando Barata, MD
Principal Investigator
Grupo Portugues de Estudo do Cancro do Pulmao
Portugal: National Pharmacy and Medicines Institute
2006-000537-35
NCT00561054
March 2007
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