RANDOMIZED PHASE II STUDY OF SORAFENIB PLUS GEMCITABINE OR SORAFENIB PLUS ERLOTINIB IN ADVANCED NON SMALL CELL LUNG CANCER (NSCLC) ELDERLY OR PS 2 PATIENTS - GEST

SECONDA UNIVERSITA' DEGLI STUDI DI NAPOLI0 个研究点开始时间: 2007年6月21日最近更新: 2012年3月19日

试验速览

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•Signed written informed consents Male or female > 70 years of age with ECOG PS 0-2 or < 70 years of age with PS 2 Diagnosis of cito-histologically confirmed NSCLC No prior chemotherapy Presence of at least one bi-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area Life expectancy of > ugual 3 months Neutrophils > ugual 1.5 x 109/L, platelets > ugual 100 x 109/L, and hemoglobin > ugual 9 g/dL Bilirubin level either normal or < 1.5 x ULN ASAT and ALAT < ugual 2.5 x ULN (< 5 x ULN if liver metastasis are present) Serum creatinine < ugual 1.5 x ULN Alkaline phosphatase < ugual 4 x ULN PT-INR/PTT < 1.5 x upper limit of normal (Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care 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) no
•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

•Brain metastases Previous 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 Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy Hystory of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiering anti-arrythmic therapy( beta blockers or digoxin are permitted) or uncontrolled hypertension. Patients with evidence or history of bleeding diathesis History of HIV infection or chronic hepatitis B or C Patients undergoing renal dialysis Acute or sub acute intestinal occlusion or history of inflammatory bowel disease Known grade 3 or 4 allergic reaction to any of the components of the treatment. Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity 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 Women who are pregnant or breastfeeding Acute or sub acute intestinal occlusion Clinically relevant peripheral neuropathy Any concurrent malignancy other than non-melanoma 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)

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