Study Phase II to Determinate the Efficacy of Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy
- 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
- 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
- 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
- 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
- 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
- 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