Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination

• Status: Completed
• Trial end date: 2015-01-13
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Treatments: Sorafenib

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