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 - COIMBRA
- Conditions
- on small cell lung cancer
- Registration Number
- EUCTR2006-000537-35-PT
- Lead Sponsor
- Portuguese Lung Cancer Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 47
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method