Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy (SOGUG/0107)

Inclusion Criteria:

• Patients must give their written informed consent before any procedure related to the study is performed.
• Patients with renal clear cell carcinoma metastatic or locally advanced, histologically or cytologically documented.The patients with metastasic disease must be not condidated to curative nefrectomy as investigator criteria.
• Assessable or measurable disease according to RECIST criteria. The lesions previosly radiated is not considered as target.
• Ages equal or superior to 18 years old.
• ECOG ≤ 1
• Patients with a life expectancy superior to 12 weeks.

• Patients with adequate organic function, according to the following criteria:

  1. . Medular reserve: Neutrophils absolute count≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Haemoglobin ≥ 9g/dl
  2. . Hepatic function: Total bilirubin < 1.5 times the superior limit of normality ALT and AST < 2.5 times the superior limit of normality (< 5 times the superior limit of normality in case of liver failure due to cancer)
  3. . Seric Albumin ≥ 1.5 times the superior limit of normality
  4. . Renal Function: Cleary creatinine > 30ml/min
  5. . FEVI > LIN according to ECO or MUGA
• Patients who are capable of accomplishing the study's requirements and without any impediments to follow the instructions while on study

Exclusion Criteria:

• Pregnant or breastfeeding women. Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication. Both men and women included in the study must use an adequate contraceptive method.
• Patients that have received sistemic treatment previous to metastasic disease.
• Previous nefrectomy.
• Mayor Surgery, radiotherapy or sistemic therapy received in the last 3 weeks previous to the inclusion of the patient in the study, except paliative radiotherapy upper no target lesions.
• Radiotherapy upper > 25% bone marrow.
• Patients that are participating in any clinical trial.
• Patients with a primary cancer diagnosis in thast 3 years, except superficial basaliomas, superficial escamous carcinoma or in situ cervix carcinoma with aducuate treatment.
• Following events in the last 12 months previous to begin the treatment: myocardial infarction, unstable o severe angina, coronary/periferic place of arterial by-pass, congestive cardiac insufficiency, brain-vascular accident included transitory ischemia or lung embolism.
• Arterial uncontrolled hypertension nor controlated with drugs ( >150/100 mmHg despite adequate medical treatment).
• Cardiac arrhythmia with grade NCI CTCAE ≥2, auricular fibrillation all grade and/or QTc interval> 450mseg in men and > 470 mseg in women.
• Actually treatment with therapeutic dose with acenocumarol (except low dose for deep venous thrombosis).
• Patients that present previously known positive serology for HIV.
• Abuse of substances, clinical conditions, psychological or social, that may interfere with the patient's participation in the study or with the evaluation of the study's results.