study multicentre evaluating the effectiveness and toxicity sorafenib (nexavar®) in adult patients with uveal melanoma and metastatic dissemination

Conditions: Uveal Melanoma

Summary: the objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma. the main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day


Eligibility criteria:
inclusion criteria: * male or female over 18 years old suffering from uveal melanoma with metastasis * at least one measurable metastases by more than 10 mm acoording to response evaluation criteria in solid tumors (recist) * at least 28 days from the previous treatment (systemic or major surgery) * performance index (who ≤ 2 or ≥ 70% karnofsky) * weight loss compared to pre morbid weight \<20% in the last 12 months * white blood cells at least 3000 / mm 3, polynuclear neutrophils less than 1500 / mm3, platelets at least 100,000 / mm3, hemoglobin at least 9.0 g / dl * total bilirubin ≤1.5 x upper limit of normal (uln) (or less than or equal to 2.5 in liver metastasis), asat and alat ≤ 2.5 x uln (or ≤ 5 in liver metastasis) serum creatinine (calculated using the cockcroft-gault method) ≤ 1.5 x uln, amylase and lipase \<1.5 x uln * prothrombin rate and international normalized ratio (inr) or activated partial thromboplastin time (aptt) ≤ 1.5 x uln. possibility of using low molecular weight heparin in place of anti vitamin k treatment * higher life expectancy than or equal to 3 months * negative pregnancy test for women of childbearing age and using a method of contraception during treatment * no one benefiting from a social security scheme * informed consent and signed by the patient or his legal representative exclusion criteria: * • patient who received more than 2 lines of treatment (chemotherapy or immunotherapy), whatever the indication * major surgery (excluding the possible diagnostic biopsy) or radiation therapy in the 4 weeks preceding the inclusion * single liver metastasis treatable by surgery * active peptic ulcer, uncontrolled * other progressive malignancy or during treatment (except basal cell carcinoma) * cardiac arrhythmias requiring anti-arrhythmic (excluding beta-blockers or digoxin for chronic atrial fibrillation), active or ischemic coronary disease (myocardial infarction within the last 6 months), or heart failure\> new york heart association (nyha) class ii * bacterial or fungal infection active (grade\> 2 common toxicity criteria for adverse effects (ctcae) v4.03) * known hiv infection or chronic hepatitis b or c * cerebral or meningeal tumor metastasis (symptomatic or asymptomatic) * epileptic disease requiring anti-epileptic taken * previous history of organ transplantation or peripheral stem cells * patient kidney dialysis * concomitant treatment with cytochrome p450 3a4 (cyp3a4) inducers such as rifampin, st. john's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone * prior therapy with bevacizumab or other targeted therapy * known or suspected allergy to sorafenib * any unstable chronic illness can jeopardize patient safety or its compliance * women pregnant or lactating * coagulopathy * uncontrolled hypertension * inability to swallow * failure to submit to medical monitoring of the trial due to geographical, social or psychic * persons deprived of liberty or under supervision * patient refusing ambulatory care * patient simultaneously participating in another clinical trial